GELATIne fluid and acute kidney injury in critical illness: the GELATI trial

INTERVENTION: Intravenous 4% succinylated gelatine fluid at a dose of at least 500mL, to be delivered over less than 60 minutes, Exact dose will be determined by treating physician. The study fluid will also be used for any further fluid boluses required within the next 24‐hour period, up to a maximum of 50mL/kg or 3000mL. Any fluid required for blood volume expansion beyond 24 hours is open‐label; however, the use of gelatine will be not allowed for 7 days post‐enrolment. Other crystalloid fluids or blood products may be used for purposes other than blood volume expansion, such as maintenance requirements or transfusion. Use of albumin solution is also permitted, if specifically indicated. Volume and type of all fluids delivered with 7 days of enrolment, or until ICU discharge, will be recorded. CONDITION: Acute kidney injury Circulatory failure Critical illness PRIMARY OUTCOME: A difference in the change in urine cystatin C concentrations over time after first dose of study fluid A difference in the change in urine NGAL concentrations over time after first dose of study fluid SECONDARY OUTCOME: 60‐day all‐cause mortality ICU‐free days within 28 days after randomisation Maximum KDIGO AKI stage within 7 days after randomisation RRT‐free days within 28 days after randomisation Urinary F2‐isoprostanes concentration ; Urinary a1‐microglobulin concentration INCLUSION CRITERIA: 1. Patient within 96 hours of ICU admission 2. Treating physician has made a clinical decision to administer a fluid bolus at a dose of at least 500mL delivered over <60 minutes 3. Presence of a urinary collection system 4. Treating physician believes there is an equipoise in using either GELO or CSL for intravascular volume expansion.