Does Terlipressin Improve Renal Outcome After Liver Surgery

NCT02368249 | Withdrawn Phase 2 DMC

• 1 other identifier: 2012-0581
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• serum creatinine peak level within 48 hours post-operative

  within 48 hours post-operative

Secondary Outcomes (6)

• the urinary output/24h

  Post Operative Day 0 to 3

• Need for hemofiltration and/or hemodialysis

  Post Operative Day 0 - 14

• Morbidity & mortality

  Post Operative Day 0 - 14

• Liver function

  Post Operative Day 0 - 5

• length of hospital stay

  Post Operative Day 0 - 14

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Drug: Placebo

Terlipressin Group

EXPERIMENTAL

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

Drug: Terlipressin

Interventions

Terlipressin DRUG

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

Also known as: Gylpressin

Terlipressin Group

Placebo DRUG

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

Also known as: Ringer's lactate solution

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

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

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Terlipressin; Ringer's Lactate

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pierre-Alain Clavien, MD PhD

  Departement of Visceral and Transplantation Surgery Zurich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 23, 2015
• Study Start: January 1, 2020
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

CH (1)