CRTSAKI 2021.

Study name	CRRT timing in sepsis‐associated AKI in ICU (CRTSAKI)
Methods	Study design: parallel, open‐label RCT Duration of study: expected to last for 4 years; recruitment of participants started in August 2019 Duration of follow‐up: for primary outcome until 90 days from the date of randomisation (day 0)
Participants	Setting: multicentre (13 ICUs) Country: China Health status: critically ill patients with sepsis (sepsis‐3) and AKI at stage 2 of KDIGO classification; aged 18 and 90 years Exclusion criteria: presence of one of the emergent CKRT conditions before randomisation: hyperkalaemia > 6.0 mmol/L or > 5.5 mmol/L persisting despite medical treatment; acute pulmonary oedema due to fluid overload responsible for severe hypoxaemia requiring oxygen flow rate > 5 L/min to maintain a percutaneous oxygen saturation > 95% or a fraction of inspired oxygen > 50% in patients already on invasive or non‐invasive mechanical ventilation and despite diuretic therapy; BUN > 112 mg/dL (40 mmol/L); pre‐existing severe CKD; previous KRT; prior kidney transplant; AKI caused by permanent postrenal obstruction or surgical lesion of renal vessel; pregnancy; hepatorenal syndrome; AIDS; survival to 90 days is unlikely due to end‐stage diseases; moribund with expected death within 24 hours; included in another interventional clinical trial
Interventions	KRT modality CKRT Intervention group Early CKRT group: patients will initiate CKRT as fast as possible. A maximum of 8 hours after randomisation Control group Delayed CKRT group: patients will initiate CKRT if AKI develops to stage 3 of KDIGO classification or when one of the emergent CKRT conditions after randomisation Hyperkalaemia > 6.0 mmol/L Acute pulmonary oedema BUN > 112 mg/dL (40 mmol/L)
Outcomes	Primary outcome Death at day 90 Secondary outcomes Death at day 28 and 1 year Recovery rate of kidney function by day 28 and 90 ICU and hospital length of stay Percentage of receipt of CKRT at least once in the delayed group Number of days alive without CKRT, mechanical ventilation and vasopressor between day 0 and up to day 90 SOFA score at day 0, day 1, day 3, day 7, day 14 and day 28 Impacts on other organ functions (heart, lung, liver) Rate of complications potentially related to CKRT: (a) major bleeding associated with anticoagulants (b) thrombosis of a large venous axis diagnosed by Doppler ultrasound, (c) catheter‐related bloodstream infection (d) thrombocytopenia (< 6.5 mmol/L), (e) hypothermia, (i) hypokalaemia Cost analysis of CKRT Duration between randomisation to CKRT initiation Duration between appearance of at least one of the criteria that initiated CKRT in the delayed group and actual initiation New biomarkers of AKI Concentrations of inflammatory mediators in serum in two groups IL1, IL6 and tumour necrosis factor α (TNF‐α)
Starting date	5 June 2017
Contact information	xiongxuming9@126.com
Notes	Last update posted: December 2021 Recruitment status: recruiting