Does Terlipressin Improve Renal Outcome After Liver Surgery (TIROL)

May 2, 2017 updated by: Ksenija Slankamenac, University of Zurich

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Department of Visceral and Transplantation Surgery of the University Hospital of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Study Director: Pierre-Alain Clavien, MD PhD, Departement of Visceral and Transplantation Surgery Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

February 1, 2025

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimate)

February 23, 2015

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0581

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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