ARGIPRESSIN for Liver transplantation | Acute kidney injury

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Any adult patient with a scheduled liver transplantation"}
• {"criterion_text":"- All participants will need to be given clear information about the study and give signed informed consent"}
• {"criterion_text":"- Person affiliated to the Social Security"}

Exclusion criteria

• {"criterion_text":"- Super-emergency for liver transplantation or fulminant hepatitis"}
• {"criterion_text":"- Pregnancy or breastfeeding"}
• {"criterion_text":"- Patient listed for or receiving simultaneous liver-kidney transplantation (SLKT)"}
• {"criterion_text":"- Patients with end-stage renal disease (chronic eGFR < 15 mL/min/1.73 m2 or requiring extra-renal purification before liver transplantation"}
• {"criterion_text":"- Patient with epilepsy"}
• {"criterion_text":"- Hypersensitivity to arginine-vasopressin and to its excipients"}
• {"criterion_text":"- Patient refusal"}
• {"criterion_text":"- Patients for whom it is impossible to give informed consent (language barrier)"}
• {"criterion_text":"- Adults under guardianship or trusteeship, persons deprived of their liberty"}
• {"criterion_text":"- Patient enrolled in another interventional clinical study"}

Primary endpoints

• {"endpoint_text":"- Stages of AKI according to AKI Network criteria (KDIGO score) during the first 7 postoperative days","definition_or_measurement_approach":"Measured as stages of acute kidney injury using AKI Network criteria (KDIGO score) during the first 7 postoperative days."}

Secondary endpoints

• {"endpoint_text":"- The number of packed red blood cells and fresh frozen plasma transfused intraoperatively and during the first 12 hours postoperatively","definition_or_measurement_approach":"Measured as count/units of packed red blood cells and fresh frozen plasma transfused intraoperatively and during the first 12 postoperative hours."}
• {"endpoint_text":"- The need for renal replacement for replacement therapy (RRT) in ICU","definition_or_measurement_approach":"Recorded need for renal replacement therapy (RRT) in intensive care unit."}
• {"endpoint_text":"- Average intraoperative norepinephrine concentrations","definition_or_measurement_approach":"Measured as average intraoperative concentrations of norepinephrine."}
• {"endpoint_text":"- Average intraoperative concentrations of other vasopressors and inotropes (Adrenalin, Dobutamine)","definition_or_measurement_approach":"Measured as average intraoperative concentrations of other vasopressors and inotropes (e.g., adrenaline, dobutamine)."}
• {"endpoint_text":"- Number of platelets transfused intraoperatively and during the first 12 hours postoperatively","definition_or_measurement_approach":"Measured as count/units of platelets transfused intraoperatively and during the first 12 postoperative hours."}
• {"endpoint_text":"- Amount of vascular filling solutions intraoperatively and during the first 12 hours postoperatively","definition_or_measurement_approach":"Measured as volume/amount of vascular filling solutions administered intraoperatively and during the first 12 postoperative hours."}
• {"endpoint_text":"- Sequential Organ Failure Assessment (score SOFA) on the third postoperative day","definition_or_measurement_approach":"Measured using the Sequential Organ Failure Assessment (SOFA) score on the third postoperative day."}
• {"endpoint_text":"- Number of days alive outside intensive care unit during the 30 day post-operation","definition_or_measurement_approach":"Measured as number of days alive and not in intensive care during the 30 days following operation."}
• {"endpoint_text":"- Mortality at 30 days","definition_or_measurement_approach":"All-cause mortality measured at 30 days post-operation."}

France

Earliest CTIS Part Ii Submission Date

22-12-2023

Latest Decision Or Authorization Date

19-12-2025

Processing Time Days

728

Number Of Sites

9

Number Of Participants

304

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France