NCT01921985

Terlipressin Administration in Patients Undergoing Major Liver Resection

Terlipressin Administration in Patients Undergoing Major Liver Resection: a Prospective Randomized Blinded Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates if the administration of terlipressin reduces complications after major liver surgery.

Detailed description

Background Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. The prerequisite for successful and safe liver surgery is the optimal regeneration of the remaining hepatic tissue in order to fulfill the metabolic demands of the patient. Liver regeneration depends on a correct portal pressure and portal blood flow. In the preliminary results the investigators show an elevation of portal pressure post partial hepatectomy in mice. Pharmacologic reduction of such elevated portal pressure using terlipressin, a vasopressin agonist, was associated with improved liver regeneration. Objective Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. Liver regeneration depends on a correct portal pressure and portal blood flow. Pharmacologic reduction of elevated portal pressure using terlipressin, a vasopressin agonist, is potentially associated with improved liver regeneration. Aim: To perform a prospective randomized trial comparing terlipressin versus placebo in patients undergoing major hepatic resection. Methods

Conditions

• Liver Resection
• Liver Failure

Interventions

Type	Name	Description
DRUG	Terlipressin	Terlipressin given as intravenous injections of 1mg iv in 100ml of NaCl every 6 hours (total duration of drug administration 120 hours, cumulative dose is 20mg).
DRUG	Placebo	Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours).

Timeline

• Start date: 2013-11-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2013-08-14
• Last updated: 2018-03-29

Locations

1 site across 1 country: Switzerland