NCT03343340.

Study name	Early versus late continuous kidney replacement therapy in acute on chronic liver failure patients with septic shock and acute kidney injury a randomized controlled trial
Methods	Study design: parallel, open‐label RCT Estimated study start date: September 2017 Duration of follow‐up: for primary outcome until 24 days from the date of randomisation (day 0)
Participants	Country: China Health status: patients with acute chronic liver failure and septic shock with AKI; ≥ 18 years Exclusion criteria: < 18 years; severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD); pregnancy; CKD on HD; hepatorenal syndrome, post‐renal obstructive AKI, AKI due to GN, interstitial nephritis or vasculitis; patients already meeting emergency criteria for immediate HD at the time of randomisation (serum potassium > 6 meq/L, metabolic acidosis pH < 7.12, acute pulmonary oedema, severe volume overload with hypoxaemia non‐responsive to diuretic treatment); patients transferred from other hospitals who have already been on HD before their arrival in the ICU; extremely moribund patients with an expected life expectancy < 24 hours; failure to get informed consent from family members; haemodynamic instability requiring very high dose of vasopressors
Interventions	Intervention group Early CKRT within 6 hours + standard medical therapy Control group Late CKRT + standard medical therapy
Outcomes	Primary outcome Transplant‐free survival at day 28 Secondary outcomes Incidence of intradialytic hypotension: decrease in SBP by ≥ 20 mm Hg or a decrease in MAP by 10 mm Hg associated with symptoms at 1 year Haemodynamic stability: maintenance of MAP on dialysis without an increase in the vasopressors at 1 year Dialysis efficiency as measured by URR at 48 hours Recovery in kidney functions defined: increase in urine output > 400 mL/day by 1 year Duration of mechanical ventilation and ICU stay by 1 year Improvement in SOFA (by 2 points) scores at 1 year Improvement in APACHE (by 2 points) scores at 1 year Improvement in MELD (by 2 points) scores at 1 year Improvement in lactic acidosis and lactate clearance at 6 hours after initiation of CKRT within 6 hours Improvement in lactic acidosis and lactate clearance at 12 hours after initiation of CKRT within 12 hours Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of CKRT within 24 hours
Starting date	17 November 2017
Contact information	rakhi_2011@yahoo.co.in
Notes	Last update posted: 17 November 2017 Recruitment status was: recruiting

AIDS: acquired immune deficiency syndrome; AKI: acute kidney injury; AKIN: Acute Kidney Injury Network; APACHE: Acute Physiology and Chronic Health Evaluation; BUN: blood urea nitrogen; CKD: chronic kidney disease; CKRT/CRRT: continuous kidney/renal replacement therapy; COPD: chronic obstructive pulmonary disease; CVVHF: continuous venovenous haemofiltration; ESKD: end‐stage kidney disease; GN: glomerulonephritis; HD: haemodialysis; KDIGO: Kidney Disease: Improving Global Outcomes; KRT ‐ kidney replacement therapy; MAP: mean arterial pressure; MELD: Model for End Stage Liver Disease; RCT ‐ randomised controlled trial; SBP: systolic blood pressure; SCr: serum creatinine; SLED: Sustained Low Efficiency Dialysis; SOFA: Sequential Organ Failure Assessment; URR: urea reduction ratio