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Trial record 2 of 22 for:    Preserve | Switzerland

Does Terlipressin Improve Renal Outcome After Liver Surgery (TIROL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02368249
Recruitment Status : Withdrawn (no focus on this topic)
First Posted : February 23, 2015
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Ksenija Slankamenac, University of Zurich

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
Kidney Failure Drug: Terlipressin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
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)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Gylpressin




Primary Outcome Measures :
  1. serum creatinine peak level within 48 hours post-operative [ Time Frame: within 48 hours post-operative ]

Secondary Outcome Measures :
  1. the urinary output/24h [ Time Frame: Post Operative Day 0 to 3 ]
  2. 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

  3. 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

  4. Liver function [ Time Frame: Post Operative Day 0 - 5 ]
    assessed by serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)

  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

  6. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368249


Locations
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Switzerland
Department of Visceral and Transplantation Surgery of the University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Study Director: Pierre-Alain Clavien, MD PhD Departement of Visceral and Transplantation Surgery Zurich
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Responsible Party: Ksenija Slankamenac, MD PhD, University of Zurich
ClinicalTrials.gov Identifier: NCT02368249    
Other Study ID Numbers: 2012-0581
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Terlipressin
Antihypertensive Agents
Vasoconstrictor Agents