Does Terlipressin Improve Renal Outcome After Liver Surgery

NCT ID: NCT02368249

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2025-02-28

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.

Conditions

Kidney Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control Group

Patients receiving post-operative placebo (Ringer lactate solution) treatment to preserve the renal function

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients are receiving a post-operative intravenous Ringer's lactate solution

Terlipressin Group

Patients receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function

Group Type: EXPERIMENTAL

Terlipressin

Intervention Type: DRUG

Patients are receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function

Interventions

Terlipressin

Patients are receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function

Intervention Type: DRUG

Placebo

Patients are receiving a post-operative intravenous Ringer's lactate solution

Intervention Type: DRUG

Other Intervention Names

Gylpressin; Ringer's lactate solution

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Ksenija Slankamenac

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pierre-Alain Clavien, MD PhD

Role: STUDY_DIRECTOR

Departement of Visceral and Transplantation Surgery Zurich

Locations

Department of Visceral and Transplantation Surgery of the University Hospital of Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2012-0581

Identifier Type: -

Identifier Source: org_study_id