Kidney Failure
Conditions
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.
Interventions
DRUGTerlipressin
Patients are receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function
DRUGPlacebo
Patients are receiving a post-operative intravenous Ringer's lactate solution
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum creatinine peak level within 48 hours post-operative | within 48 hours post-operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| the urinary output/24h | Post Operative Day 0 to 3 | — |
| 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 |
| 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 |
| Liver function | Post Operative Day 0 - 5 | assessed by serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) |
Countries
Switzerland
Outcome results
None listed