Does Terlipressin Improve Renal Outcome After Liver Surgery

Phase 2

Withdrawn

• Conditions: Kidney Failure
• Interventions: Drug: Placebo; Drug: Terlipressin

• Registration Number: NCT02368249
• Lead Sponsor: University of Zurich

Brief Summary

The investigators aim to address whether terlipressin improves the renal outcome after liver surgery. Therefore the investigators are planning to conduct a double-blinded randomized control trial. The investigators will randomize patients undergoing any kind of liver surgery and being at increased moderate to high risk for post-operative acute renal failure into a control group receiving post- operative a placebo or into a group receiving post-operatively terlipressin in combination with human albumin.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-23
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05
• Study Start: 2020-01
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• >=12% risk for post-operative ARF on our recently developed and validated prediction score for ARF after liver surgery, patients will need five points or more in the pre-operative assessment of the predictors to be enrolled in the trial

Exclusion Criteria

• < 18 years
• liver cirrhosis
• coronary insufficiency with ST-elevation or ST-depression in the - - intra-operative ECG as signs of an acute coronary syndrome
• pregnancy and breast feed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	Patients receiving post-operative placebo (Ringer lactate solution) treatment to preserve the renal function
Terlipressin Group	Terlipressin	Patients receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function

Primary Outcome Measures

Name	Time	Method
serum creatinine peak level within 48 hours post-operative	within 48 hours post-operative

Secondary Outcome Measures

Name	Time	Method
Morbidity & mortality	Post Operative Day 0 - 14	measured by the comprehensive complication index; participants will be followed for the duration of hospital stay, an expected average of 14 days
length of ICU stay	Post Operative Day 0 - 7	in days; participants will be followed for the duration of ICU stay, an expected average of 7 days
the urinary output/24h	Post Operative Day 0 to 3
Liver function	Post Operative Day 0 - 5	assessed by serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
length of hospital stay	Post Operative Day 0 - 14	in days; participants will be followed for the duration of hospital stay, an expected average of 14 days
Need for hemofiltration and/or hemodialysis	Post Operative Day 0 - 14	participants will be followed for the duration of hospital stay, an expected average of 14 days

Trial Locations

Locations (1)

Department of Visceral and Transplantation Surgery of the University Hospital of Zurich; 🇨🇭 Zurich, Switzerland