NCT02698930
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NCT02607163
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NCT02875873
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Need for plasma expansion, and the clinician considers that Plasma-Lyte® or 0.9% saline are equally appropriate for patients, with no specific indications or contraindications for any of the fluids or for rapid or slow infusion.
Patients not expected to be discharged on the day after their admission.
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At least one of the following risk factors for acute renal injury:
Age ≥ 65 years
Hypotension (mean arterial pressure [MAP] < 65 mmHg or systolic blood pressure [SBP] < 90 mmHg) or use of vasopressors
Sepsis
Use of invasive mechanical ventilation or of continuous noninvasive mechanical ventilation (including high-flow nasal cannula) > 12 hours
Oliguria (< 0.5 mL/kg/hour for ≥ 3 hours)
Serum creatinine ≥ 1.2 mg/dL for women or ≥ 1.4 mg/dL for men
Liver cirrhosis or acute liver failure
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NCT03277677
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Age ≥ 18 years old
Who need fluid resuscitation in the Emergency Room (ER)
Who have fulfilled the criteria for sepsis/septic shock within the previous 24 hours according to sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection
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Patients with infection and resulted from a hosťs systemic inflammatory response syndrome (SIRS) to infection are defined as sepsis if meet the criteria 2 or more of
Temperature >38°C or <36°C
Heart rate >90/min
Respiratory rate >20/min or PaCo2 <32 mm Hg (4.3 kPa)
White blood cell count >12000/mm3 or <4000/mm3 or >10% immature bands.
Patient who have Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality.
Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
AND where informed consent is obtainable either from the patient or by proxy (first degree relative, spouse) if patients arenť in fully conscious status (e.g. comatose, drowsiness, irritable).
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NCT03188614
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NCT02980003
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Consecutive patients scheduled for coronary angiography and/or angioplasty;
eGFR <60 mL/min/1.73 m2, but >15 mL/min/1.73 m2 (MDRD formula).
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NCT02799368
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Individuals aged 18 years or older
with eGFR < 45 mL/min/1.73m2 or eGFR < 60 mL/min/1.73m2 who have at least one condition Diabetes mellitus Age > 60 year
Able and willing to provide informed consent
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NCT02793661
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Age > 18 years old
15 ml/min/m2 ≤ eGFR ≤ 40 ml/min/m2
High volume contrast-requiring cardiovascular procedures (estimated contrast volume > 3 times eGFR value)
Patient has agreed to all FU testing
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NCT02974946
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Patients undergoing surgery (elective or in-house urgent)
Patient 18 years old and over
Patient able to give written consent
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Patient at risk of developing AKI after cardiac surgery (at least one factor)
Diabetics (IDDM or NIDDM) with normal kidney function pre-op
Patients with eGFR 20-60
Patients undergoing combined cardiac procedures when the CPB time is likely to exceed 120 minutes
Patients with Hb of 12.5 g/dl or below
Logistic Euroscore of 5 and above
Patient not involved with another study
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NCT01866800
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Subject is 65 years old who is able and willing to give an informed consent.
Patients undergoing planned trans-femoral TAVI.
Calculated eGFR below 60ml/min/1.73m2 (MDRD)
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NCT03509935
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NCT02481518
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Age > 18 years
Eastern Cooperative Oncology Group score 0-2
First Diagnosed Head and neck cancer and plan for treatment with cisplatin
Serum creatinine ≤1.5 mg/dl or eGFR≥60(ml/min/1.73 m2)
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NCT03056248
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A male or female greater than 18 years
Stable renal function with creatinine change <0.3mg/dl in the preceding 1 month prior to scheduled surgery
Procedure such as aortic valve surgery, mitral valve surgery, coronary artery bypass grafting, or combination of the above mentioned procedures
Have estimated glomerular filtration rate greater than or equal to 15ml/min/ 1.73m2 as calculated by chronic kidney disease Epidemiology Collaboration (CKD-EPI) formula
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NCT03331146
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Patients CCFS score ≥ 6
Patients admitted to UAB cardiac intensive care unit (CICU) following elective cardiac surgery with cardiopulmonary bypass under general endotracheal anesthesia
19 years old
Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2
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NCT03476460
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Patients >65 years,
Both sexes,
With at least one of the following criteria: diabetes or stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min),
Undergoing CT scan with contrast
Written informed consent.
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NCT03396770
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NCT02531412
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Patients admitted to the ICU in the immediate postoperative period (first 24 hours) of major surgery, defined as involving general anesthesia, ventilation, opening of large cavities (cranial, thoracic, abdominal).
Patients with informed consent signed by them or their responsible relative.
Patients who are likely to survive at least 48 hours after admission to the ICU.
Patients who have measured "baseline" creatinine before UCI admission, in the last three months.
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NCT03206658
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Patients older than 18 years of age
Patients critically ill requiring invasive mechanical ventilation with some organic failure in addition to respiratory failure.
Organic scale failure will be categorized according to the (Sequential Organ Failure Assessment) scale and will be considered present when there is a score ≥2 in some organ / system, except renal.
Patients with normal renal function or chronic kidney disease KDOQI 1-3
Patients without acute renal injury according to the (acute kidney injury network) AKIN criteria.
Normal serum K levels (less than or equal to 5 mEq / L).
Women with (a) negative pregnancy test, (b) surgical sterilization, or (c) completed menopause.
Systolic blood pressure> 90 mmHg and mean arterial pressure> 70 mmHg.
Diuresis in the first 6 hrs. from admission to intensive therapy> 0.5 ml / kg / hr.
The patient will give written and signed informed consent prior to any specific study procedure. However, if a patient cannot do so before, his or her legal representative the Institute may give written informed consent.
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NCT03329443
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NCT01275729
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18 yrs. or older
increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater than or equal to 150% from baseline or sustained oliguria (UOP < 0.5 cc/kg/hr. for 6 hours with the last 48hours)
written informed consent
patients with an indwelling bladder catheter
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NCT02983422
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NCT02771509
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Patient is either male or female ≥ 18 years.
Patient has provided written informed consent, and is willing and able to comply with the requirements of the study protocol, including screening procedures.
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Patient must be scheduled for and undergo a non-emergent cardiac surgical procedure involving CPB. Eligible procedures include:
Coronary artery bypass graft (CABG) alone
Aortic valve replacement or repair alone, with or without aortic root repair
Mitral, tricuspid, or pulmonic valve replacement or repair alone
Combined replacement of several cardiac valves
CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
CABG with combined cardiac valve replacement or repair.
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Patient must have the following risk factor(s) for AKI prior to surgery:
Estimated glomerular filtration rate (eGFR) of ≥ 20 and < 30 ml/min/1.73m2, or
eGFR ≥ 30 and < 60 mL/min/1.73m2 and ONE of the following Additional Risk Factors (other than age ≥ 75 years), or
eGFR ≥ 60 ml/min/1.73m2 and TWO of the following Additional Risk Factors
eGFR will be calculated using the abbreviated MDRD equation (MDRD-4, often referred to as the Levey equation): eGFR = 186.3 x sCr-1.154 x Age-0.203 x [0.742 if Female] x [1.212 if Black]
Additional Risk Factors:
Combined valve and coronary surgery
Previous cardiac surgery with sternotomy
Left ventricular ejection fraction (LVEF) < 35% by invasive or noninvasive diagnostic cardiac imaging within 90 days prior to surgery
Diabetes mellitus requiring insulin treatment
Non-insulin-requiring diabetes with documented presence of at least moderate (+2) proteinuria on urine analysis (medical history or dipstick)
Documented NYHA Class III or IV within 1 year prior to index surgery
Age ≥ 75 years can be considered an Additional Risk Factor only for patients with eGFR ≥ 60 ml/min/1.73m2.
Patient must have presented for surgery without prior evidence of active renal injury defined as no acute rise in sCr > 0.3 mg/dL or no 50% increase in sCr between the time of Screening and pre-surgery.
Patienťs body mass index (BMI) < 35 at Screening.
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Female patients of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year):
Must have a negative serum pregnancy test prior to surgery.
Must agree (1) to use 2 forms of effective birth control regimen (at least one-barrier method) during the 90-day study period or (2) to maintain total abstinence throughout the 90-day study period.
Male patients must agree to use condoms or other suitable means of pregnancy prevention such as abstinence during the 90-day study period.
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NCT02474667
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All patients must provide written informed consent using an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved consent form, and must understand and be willing and able to comply with the requirements of the study, including screening procedures and all required study visits.
Males and females ≥ 18 years of age.
Oligoanuric renal failure (less than 200 mL of UO per day) requiring hemodialysis or peritoneal dialysis initiated at least 3 months prior to transplantation.
Patient is to be the recipient of a first kidney transplant from a deceased donor.
Study drug can be administered starting within 30 hours after restoration of blood flow to the engrafted kidney.
Body mass index < 35 based on dry weight. Dry weight and height parameters obtained within 7 days prior to study entry may be used.
Estimated donor organ cold ischemia time less than 30 hours (for PMP kidneys less than 40 hours).
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Females of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year):
Must have a negative serum pregnancy test prior to transplantation. Must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the initial 30-day study period OR agree to maintain total abstinence throughout the initial 30-day study period.
Male patients must agree to use condoms or other suitable means of pregnancy prevention such as abstinence during the initial 30-day study period.
Patient has poor renal function in the first 24 hours post-transplantation based on an average UO of less than 50 mL per hour over any 8 consecutive hours, to maximize the likelihood that the patient requires dialysis within the first 7 days post-transplant, irrespective of pre-transplant donor and recipient risk factors.
Reason for low UO is not due to structural or vascular abnormalities which, when indicated should be confirmed with a renal ultrasound with Doppler study and/or vascular or urinary tract contrast studies.
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NCT02808351
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Planned diagnostic coronary or peripheral artery angiography
Type 2 diabetes mellitus
CKD stages ≥2
Statin naive, or not on statin treatment for at least 14 days
Withdrawal metformin or aminophylline for 48h before angiography
Total iodixanol volume
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NCT02869347
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Estimated glomerular filtration rate (eGFR) of <50 ml/min/1.73m2
At least one of the following risk factors: diabetes mellitus, age at least 75 years, anemia (baseline hematocrit value less or equal 39% for men and less or equal 36% for women), congestive heart failure class III or IV by New York Heart Association classification, history of pulmonary edema.
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NCT02962102
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Age ≥ 18
Admitted to the ICU within 48h prior to enrollment
Likely to remain in the ICU (alive) for ≥72h
Naso/orogastric tube or ability to swallow
High risk of severe AKI
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NCT03401710
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NCT03007537
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Preoperative hemoglobin<130g/L;
Surgery: valve, coronary artery bypass graft or surgery for congenital heart diseases;
Volunteers with informed consent.
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NCT02665377
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NCT02836899
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Provide written informed consent
Age ≥ 18 years of age
Elective cardiac or aortic surgery with CPB>90 minutes
Stable pre-operative renal function without evidence of plasma creatinine level increase of ≥ 0.3 mg/dL over the prior 3 months and without renal replacement therapy (RRT).
Clinical evidence of endothelial dysfunction assessed by a specifically designed questionnaire.
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NCT02664753
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The emergency inclusion procedure was correctly applied according to French law (signature of consent form by a patient-designated trusted person or a family member, or a medical decision to proceed with patient inclusion if the latter two persons are unavailable) ---- OR ---- signature of the consent form by the patient
The patient must be insured or beneficiary of a health insurance plan
The patient is at least 18 years old
The patient has been admitted to a participating ICU for severe sepsis or septic shock within the last 72 hours
The patient has sepsis or septic shock according to international criteria SEPSIS 3 (Singer et al, The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); JAMA 2016).
The patient has acute renal insufficiency with an KDIGO score of 3
The patient has started continuous renal replacement therapy (CRRT) or intermittent renal replacement therapy (IRRT) within the past 24 hours, or will start RRT (CRRT or IRRT) within the next 24 hours
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NCT02531724
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Patients in the cardiothoracic intensive care after cardiac surgery with cardiopulmonary bypass
Acute kidney injury, defined as increase in S-creatinine 50% or 27 mol/L
Normal S-creatinine before surgery
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NCT01720030
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NCT03510897
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Male or female, age ≥ 18 years old
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At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors:
Reduced renal function
Diabetes with ongoing insulin treatment
Albuminuria
Undergoes non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest
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NCT03403751
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Has either suspected or documented diagnosis of abdominal sepsis requiring treatment with parenteral antibiotics and planned or completed surgical (laparotomy or laparoscopy) or interventional radiologic procedures within 24 hours of evaluation by medical personnel. Recommended surgical or interventional radiologic procedures be performed with 12 hours of evaluation by medical personnel.
Initial diagnosis of AKI Stage 2 or 3 according to KDIGO AKI criteria established either upon presentation to medical care in those patients with suspected abdominal sepsis or in those patients in whom the initial diagnosis of AKI is established during the 48-hour period from the suspected diagnosis of abdominal sepsis.
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Study medication must be administered within 6 hours of confirmation of onset of Stage 2 or 3 AKI as established at the study site, under the following criteria:
After the decision is made by the attending surgeon at the study site for a surgical or interventional radiology procedure for the abdominal infection OR
After confirmed diagnosis of abdominal infection has been established by a surgical or interventional radiology procedure
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NCT03526367
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Age 18-80 years old
The STEMI patients within 12 h of onset (or within 12-24 h of onset with chest pain and persistent ST-segment elevation or the presence of a new LBBB);
The patients planned primary PCI;
At least one of the following:
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NCT03273751
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Adult patients scheduled to undergo open, laparoscopic, or robot-assisted laparoscopic partial nephrectomy
Normal contralateral renal function was defined as split renal function of >40% as determined by preoperative Tc-99m DiethyleneTriamine Pentaacetic Acid (DTPA) kidney scan
Written informed consent
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NCT03236441
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Patient with non-ST elevation myocardial infarction or unstable angina
Referral for cardiac catheterization and percutaneous coronary intervention
Contrast-induced acute kidney injury risk score of ≥11
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NCT02997748
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NCT02518087
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Patients with more than 18 years old.
Non emergent cardiac surgery patients requiring expected CPB time > 60 minutes: double valve replacement or valve replacement plus coronary arterial bypass graft (CABG).
Written informed consent from patient or legal surrogates.
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NCT03384875
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Scheduled for non-emergent cardiac surgery requiring CPB for i) heart valve replacement with any other procedure, without hypothermic circulatory arrest (HCA), or ii) aortic reconstruction with or without another procedure, with HCA
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NCT02250131
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NCT03373318
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NCT02568722
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Age ≥ 18 years
Admission to an intensive care unit (ICU)
Evidence of kidney dysfunction [serum creatinine ≥100 µmol/L (women) and ≥ 130 µmol/L (men)]
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Evidence of severe AKI defined by at least 1 of the following 3 criteria:
i) ≥ 2-fold increase in serum creatinine from a known pre-morbid baseline or during the current hospitalization; OR ii) Achievement of a serum creatinine ≥ 354 µmol/L with evidence of a minimum increase of 27 µmol/L from pre-morbid baseline or during the current hospitalization; OR iii) Urine output < 6.0 mL/kg over the preceding 12 hours
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NCT02937935
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Patients with cirrhosis (diagnosed based on clinical, biochemical, radiological or histological diagnosis) with stage 3 Acute Kidney Injury defined as an increase of serum creatinine to more than 300 fold and more than 4 mg/dl.
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NCT03343340
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NCT03396757
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All of the following criteria must be fulfilled to be included in the observational study (first stage):
Adults (>18 years)
Hospitalized in a study ICU.
Evidence of acute kidney injury compatible with the diagnosis of acute tubular necrosis in a context of ischemic or toxic aggression and who receive (or received for the same episode) invasive mechanical ventilation and/or catecholamine infusion.
Acute kidney injury stage 3 of KDIGO classification defined by at least one of the following criteria: serum creatinine concentration of more than 4 mg/dl (354 µmol/liter) or greater than 3 times the baseline creatinine level, anuria (urine output of 100 ml/day or less) for more than 12 hours, oliguria (urine output below 0.3 ml/kg/h or below 500 ml/day) for more than 24 hours.
To be randomized (randomization stage), supplemental criteria must be fulfilled. These criteria can appear either immediately after inclusion in the observational stage, or during the follow-up of the patient in the observational stage, in the absence of any non-inclusion criteria (listed below) at the time of randomization:
Oliguria/anuria (urine output <0.3 ml/kg/h or <500 ml/day) for more than 72 hours or serum urea concentration comprised between 40 and 50 mmol/l.
Affiliation to a social security regime
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NCT02937961
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NCT03175328
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NCT01062984
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Age 18 or older and able to sign consent (or surrogate).
Must have been referred to the inpatient Nephrology consult service for evaluation of AKI.
Expected survival of at least 48 hours.
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NCT02669589
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Critically ill patients with clinical indication for CRRT (clinical decision to use continuous RRT due to hemodynamic instability)
Or
Severe acute kidney injury (KDIGO 3-classification) despite optimal resuscitation
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At least one of the following conditions
Sepsis or septic shock
Use of catecholamines (norepinephrine or epinephrine ≥ 0.1 µg/kg/min or norepinephrine ≥ 0.05 µg/kg/min + dobutamine (any dose) or norepinephrine ≥ 0.05 µg/kg/min + vasopressin (any dose) or epinephrine ≥ 0.05 µg/kg/min + norepinephrine ≥ 0.05 µg/kg/min)
Refractory fluid overload: worsening pulmonary edema: PaO2/FiO2 < 300 mmHg and/or fluid balance > 10% of body weight)
18-90 years old
Intention to provide full intensive care treatment for at least 3 days
Written informed consent of the patient or the legal representatives or the authorized representative or the inclusion due to an emergency situation
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NCT02384525
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body temperature < 36 °C or > 38 °C
heart rate > 90 BPM
respiratory rate > 20 or aPaCO2 < 32 mmHg on ABG
White blood cell count < 4,000 cells/mm3 or > 12,000 cells/mm3 or band forms (immature white blood cells) ≥10%
Evidence of infection
WBCs in normally sterile fluid
Perforated viscus
radiologically proven infection
more than Injury stage in AKI according to RIFLE criteria
septic AKI which is not explained by other cause
patients signed a written informed consent.
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NCT03329313
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Age > 18 years old
Acute kidney injury requiring renal replacement therapy
Dialysis type: on line sustained low efficiency dialysis -filtration
SOFA score > 5
Sodium serum level between 135 and 145mmol/l
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NCT03438877
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NCT02786277
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Phase 1 of the trial will enroll all inpatients at study hospitals who meet Kidney Disease: Improving Global Outcomes Stage 1 Creatinine criteria for AKI
Phase 2 and phase 3 of the trial will use a machine-learning based algorithm to target enrollment to those patients expected to derive benefit from alerting, based upon our experience in the prior trial period.
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NCT02753751
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Adult ≥ 18 years admitted to a participating study hospital
Acute Kidney Injury as defined by KDIGO consensus creatinine criteria (0.3mg/dl increase in serum creatinine over 48 hours or 50% relative increase over 7 days).
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NCT02793167
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NCT02771977
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Acute Kidney Injury based upon the Kidney Disease: Improving Global Outcomes creatinine criteria (a 0.3mg/dl increase over 48 hours or 50% increase over 7 days) and exposure within the past 24 hours to one of the following classes of medications:
Non-steroidal anti-inflammatory drug
Renin Angiotensin Aldosterone System Antagonists
Proton Pump Inhibitors
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NCT01621152
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NCT03219398
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Subjects aged 18-60 years old undergoing laparoscopic surgery, with American Society of Anesthesiologist (ASA) 1, body mass index 18-25. Patients who agreed to participate in this study and sign informed consent.
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NCT03534141
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NCT02928887
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NCT02643745
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NCT03590028
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NCT02643745
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NCT03244514
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NCT03178435
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NCT03236103
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Adult patients with VAD in place who are admitted to the hospital for acute medical illness during the study period. For those with multiple admissions during the study period only the first admission will be studied.
Patients who are able to give consent. In case of patients that are mentally impaired we will obtain consent from power of attorney and when patients regain intact mental capacity, we will reobtain consent from the patient.
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NCT03564314
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NCT02726620
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NCT02915575
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Age ≥ 18 yrs.
At least a doubling of serum creatinine during hospitalization (including need for dialysis)
Have a primary care physician (PCP)
No nephrologist follow up arranged after hospital discharge
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NCT02483039
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NCT03165552
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NCT03015623
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AKI, as determined by the Investigator based on his/her clinical judgment
Able to tolerate indwelling intravascular access
Has tolerated Continuous Renal Replacement Therapy for at least 12 hours prior to IP treatment
Likely to require Continuous Renal Replacement Therapy for at least an additional 48 hours
Ability to give informed consent
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NCT02933892
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Patients scheduled to undergo non-emergent cardiac catheterization at University Medical Center Hospital, Lubbock, TX from January 2016 to January 2018. Emergent cardiac catheterizations will be defined as a catheterization scheduled < 24 hours from a cardiac event.
Patients willing to be randomized to TFA or TRA procedure.
Patients signed and dated the informed consent agreeing to participate in the study.
Patients with chronic kidney disease, defined as eGFR = 15-59mL/min defined by the MDRD formula. (eGFR is a standard of care measurement for all patients undergoing coronary intervention.).
Patients ages 18-88 years old.
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