Status
Recruiting
Phase
Phase 3
Enrollment
304
Locations
1
Results
Not posted
Publications
12
Study summary
Liver transplantation (LT) is a high-risk surgery for hemodynamic instability and haemorrhagic shock with a high-risk of acute kidney injury (AKI). Indeed, the incidence of post-transplant AKI exceeds 50% in some series with 15% of patients requiring renal replacement therapy. Acute kidney injury after LT is a predisposing factor for chronic renal failure which is independently associated with higher morbidity and mortality. Arginine vasopressin (AVP), an essential stress hormone released in response to hypotension, binds to AVPR1a to promote vasoconstriction. Furthermore, it may have nephroprotective effects with a preferential vasoconstriction of the post-glomerular arteriole resulting in increased glomerular filtration The hypothesis of the present work is that low-dose arginine-vasopressin supplementation reduce posttransplant AKI in liver transplantation.
Prospective, national multicenter, double-blinded, randomized , controlled superiority trial with two parallel arms : AVP vs Norepinephrine The primary objective is to demonstrate that intraoperative low-dose supplementation of AVP induces a reduction in posttransplant AKI after liver transplantation Investigational medicinal product: vasopressin will be administered by continuous infusion. AVP will be used to a final concentration of 0.12 U/ml. The vasopressor infusion will be titrated to maintain an MAP of at least 65 mmHg. The study-drug infusion will be started at 5 ml/h and increased by 2.5 ml/h to achieve a maximum target rate of 30 ml/h, so that AVP doses ranged from 0.01 to 0.06 U/min. Comparator treatment : norepinephrine will be administered by continuous infusion. Norepinephrine will be used with final concentrations of 120 microg/ml. The vasopressor infusion will be titrated to maintain an MAP of at least 65 mmHg. The study-drug infusion will be started at 5 ml/h and increased by 2.5 ml/h to achieve a maximum target rate of 30 ml/h, so that NE doses ranged from10 to 60 microg/min.
Interventions
DRUG
low-dose arginine-vasopressin supplementation group: Vasopressin will be administered by continuous infusion. AVP will be used to a final concentration of 0.12 U/ml. The vasopressor infusion will be titrated to maintain an MAP of at least 65 mmHg. The study-drug infusion will be started at 5 ml/h and increased by 2.5 ml/h to achieve a maximum target rate of 30 ml/h, so that AVP doses ranged from 0.01 to 0.06 U/min.
DRUG
Norepinephrine will be administered by continuous infusion. Norepinephrine will be used with final concentrations of 120 microg/ml. The vasopressor infusion will be titrated to maintain an MAP of at least 65 mmHg. The study-drug infusion will be started at 5 ml/h and increased by 2.5 ml/h to achieve a maximum target rate of 30 ml/h, so that NE doses ranged from10 to 60 microg/min.
Timeline
First posted
Apr 3, 2024
Study start
Apr 16, 2025
Primary completion
May 16, 2025
Study completion
May 16, 2027
Results posted
Not reported
Registry updated
Feb 5, 2026
Outcomes
The primary objective is to compare the effect of intraoperative low-dose supplementation of AVP vs norepinephrine infusions on post-transplant Acute Kidney Injury after liver transplantation.
Time frame · during the first 7 postoperative days
The stages of AKI according to AKI Network criteria (KDIGO score) determined by changes in serum creatinine and changes in urine output.
To compare into the two arms the number of packed red blood cellsand fresh frozen plasma transfused
Time frame · during the first 12 hours postoperatively
To compare into the two arms the number of the Number of AKI KDIGO 1
Time frame · 1 during the first 7days
defined as increase in serum creatinine concentration by 1.5 to 1.9 fold or ≥0.3mg/dl (or 27 micromol/L) within 48h or urine output \<0.5 ml/Kg/h over a period 6-12 h)
To compare into the two arms the Number of AKI KDIGO 2
Time frame · during the first 7 postoperative
defined as increase in serum creatinine concentration by 2.0 to 2.9 fold or urine output \<0.5 ml/Kg/h over a period ≥12 h)
To compare into the Number of AKI KDIGO 3
Time frame · during the first 7 postoperative
defined as increase in serum creatinine concentration ≥ 3 fold or ≥ 4mg/dl (or 354 micromol/L) or urine output \<0.3 ml/Kg/h for ≥24h or anuria\>12h)
The need for renal replacement for replacement therapy (RRT) in ICU
Time frame · during the first 7 days postoperatively and on postoperative day 30
The number of patients remaining on dialysis at the end of the study
Time frame · on the 30th Day
Average intraoperative norepinephrine concentrations
Time frame · intraoperative
Average intraoperative concentrations of other vasopressors and inotropes (Adrenalin, Dobutamine)
Time frame · intraoperative
Number of platelets transfused intraoperatively
Time frame · during the first 12 hours postoperatively.
Amount of vascular filling solutions intraoperatively
Time frame · During the first 12 hours postoperatively.
Eligibility
Inclusion Criteria: * Age ≥ 18 years * Any adult patient with a scheduled liver transplantation * All participants will need to be given clear information about the study and give signed informed consent. * Person affiliated to the Social Security Exclusion Criteria: * Super-emergency for liver transplantation or fulminant hepatitis * Patient listed for or receiving simultaneous liver-kidney transplantation (SLKT) * Patients with end-stage renal disease (chronic eGFR \< 15 mL/min/1.73 m2 or requiring extra-renal purification before liver transplantation * Patient with epilepsy * Hypersensitivity to arginine-vasopressin and to its excipients * Patient refusal * Patients for whom it is impossible to give informed consent (language barrier) * Adults under guardianship or trusteeship, persons deprived of their liberty * Patient enrolled in another interventional clinical study * Pregnancy or breastfeeding
Study locations
France. Showing up to 24 locations stored in the fast local snapshot.
URC Lariboisière-Fernand Widal-saint Louis
Paris, France
Publications
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