Back to resultsDoes Terlipressin Improve Renal Outcome After Liver Surgery (TIROL)
Primary Purpose
Kidney Failure
Status
Withdrawn
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Terlipressin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Failure
Eligibility Criteria
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
Sites / Locations
- Department of Visceral and Transplantation Surgery of the University Hospital of Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control Group
Terlipressin Group
Arm Description
Patients receiving post-operative placebo (Ringer lactate solution) treatment to preserve the renal function
Patients receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function
Outcomes
Primary Outcome Measures
serum creatinine peak level within 48 hours post-operative
Secondary Outcome Measures
the urinary output/24h
Need for hemofiltration and/or hemodialysis
participants will be followed for the duration of hospital stay, an expected average of 14 days
Morbidity & mortality
measured by the comprehensive complication index; participants will be followed for the duration of hospital stay, an expected average of 14 days
Liver function
assessed by serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
length of hospital stay
in days; participants will be followed for the duration of hospital stay, an expected average of 14 days
length of ICU stay
in days; participants will be followed for the duration of ICU stay, an expected average of 7 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02368249
Brief Title
Does Terlipressin Improve Renal Outcome After Liver Surgery
Acronym
TIROL
Official Title
Does Terlipressin Improve Renal Outcome After Liver Surgery - A Double-Blinded Randomized Control Trial (TIROL-Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
no focus on this topic
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Patients receiving post-operative placebo (Ringer lactate solution) treatment to preserve the renal function
Arm Title
Terlipressin Group
Arm Type
Experimental
Arm Description
Patients receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Other Intervention Name(s)
Gylpressin
Intervention Description
Patients are receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Ringer's lactate solution
Intervention Description
Patients are receiving a post-operative intravenous Ringer's lactate solution
Primary Outcome Measure Information:
Title
serum creatinine peak level within 48 hours post-operative
Time Frame
within 48 hours post-operative
Secondary Outcome Measure Information:
Title
the urinary output/24h
Time Frame
Post Operative Day 0 to 3
Title
Need for hemofiltration and/or hemodialysis
Description
participants will be followed for the duration of hospital stay, an expected average of 14 days
Time Frame
Post Operative Day 0 - 14
Title
Morbidity & mortality
Description
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
Title
Liver function
Description
assessed by serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
Time Frame
Post Operative Day 0 - 5
Title
length of hospital stay
Description
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
Title
length of ICU stay
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Alain Clavien, MD PhD
Organizational Affiliation
Departement of Visceral and Transplantation Surgery Zurich
Official's Role
Study Director
Facility Information:
Facility Name
Department of Visceral and Transplantation Surgery of the University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
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Does Terlipressin Improve Renal Outcome After Liver Surgery
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