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TIROL: Does Terlipressin Improve Renal Outcome After Liver Surgery

Sponsor
University of Zurich (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02368249
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
61
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Does Terlipressin Improve Renal Outcome After Liver Surgery - A Double-Blinded Randomized Control Trial (TIROL-Trial)
Anticipated Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. serum creatinine peak level within 48 hours post-operative [within 48 hours post-operative]

    Secondary Outcome Measures

    1. the urinary output/24h [Post Operative Day 0 to 3]

    2. 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

    3. 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

    4. Liver function [Post Operative Day 0 - 5]

      assessed by serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)

    5. 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

    6. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Visceral and Transplantation Surgery of the University Hospital of Zurich Zurich Switzerland 8091

    Sponsors and Collaborators

    • University of Zurich

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ksenija Slankamenac, MD PhD, University of Zurich
    ClinicalTrials.gov Identifier:
    NCT02368249
    Other Study ID Numbers:
    • 2012-0581
    First Posted:
    Feb 23, 2015
    Last Update Posted:
    May 5, 2017
    Last Verified:
    May 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Renal Insufficiency
    Terlipressin

    Study Results

    No Results Posted as of May 5, 2017