Does Terlipressin Improve Renal Outcome After Liver Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Does Terlipressin Improve Renal Outcome After Liver Surgery - A Double-Blinded Randomized Control Trial (TIROL-Trial)

Conditions
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Kidney Failure

Intervention / Treatment
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* Drug: Terlipressin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Patients receiving post-operative placebo (Ringer lactate solution) treatment to preserve the renal function | Drug: Placebo<br>* Patients are receiving a post-operative intravenous Ringer's lactate solution<br>* Other names: Ringer's lactate solution;|
| Experimental: Terlipressin Group<br>Patients receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function | Drug: Terlipressin<br>* Patients are receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function<br>* Other names: Gylpressin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum creatinine peak level within 48 hours post-operative |  | within 48 hours post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the urinary output/24h |  | 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 | 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 | Post Operative Day 0 - 14 | 
| Liver function | assessed by serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) | 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 | 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 | Post Operative Day 0 - 7 |