Does Terlipressin Improve Renal Outcome After Liver Surgery

Kidney Failure Clinical Trial

— TIROL  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02368249
• Other study ID #: 2012-0581
• Status: Withdrawn
• Phase: Phase 2
• First received: February 9, 2015
• Last updated: May 2, 2017
• Start date: January 2020
• Est. completion date: February 2025

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• Terlipressin
Patients are receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function
• Placebo
Patients are receiving a post-operative intravenous Ringer's lactate solution

Locations

Country	Name	City	State
Switzerland	Department of Visceral and Transplantation Surgery of the University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum creatinine peak level within 48 hours post-operative		within 48 hours post-operative
Secondary	the urinary output/24h		Post Operative Day 0 to 3
Secondary	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
Secondary	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
Secondary	Liver function	assessed by serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)	Post Operative Day 0 - 5
Secondary	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
Secondary	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