Does Terlipressin Improve Renal Outcome After Liver Surgery

University of Zurich

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Kidney Failure

Interventions

TerlipressinDRUG

Patients are receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function

PlaceboDRUG

Patients are receiving a post-operative intravenous Ringer's lactate solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Visceral and Transplantation Surgery of the University Hospital of Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

serum creatinine peak level within 48 hours post-operative

Time frame: within 48 hours post-operative

Secondary Outcomes

the urinary output/24h

Time frame: Post Operative Day 0 to 3

Need for hemofiltration and/or hemodialysis

participants will be followed for the duration of hospital stay, an expected average of 14 days

Time frame: Post Operative Day 0 - 14

Morbidity & mortality

measured by the comprehensive complication index; participants will be followed for the duration of hospital stay, an expected average of 14 days

Time frame: Post Operative Day 0 - 14

Liver function

assessed by serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)

Time frame: Post Operative Day 0 - 5

length of hospital stay

in days; participants will be followed for the duration of hospital stay, an expected average of 14 days

Time frame: Post Operative Day 0 - 14

length of ICU stay

in days; participants will be followed for the duration of ICU stay, an expected average of 7 days

Time frame: Post Operative Day 0 - 7

Data from ClinicalTrials.gov

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