Terlipressin Administration in Patients Undergoing Major Liver Resection

Phase 2

Terminated

• Conditions: Liver Resection; Liver Failure
• Interventions: Drug: Placebo; Drug: Terlipressin

• Registration Number: NCT01921985
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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

Study Timeline

• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-09
• Study First Posted: 2013-08-14
• Study Start: 2013-11
• Status Verified: 2018-03
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients undergoing resection of 3 or more liver segments
• Minimum age of 18
• Any gender
• Written informed consent

Exclusion Criteria

• Preoperative renal failure (GFR < 50ml/min)
• Severe liver dysfunction (Child-Turcotte-Pugh grade C)
• Hyponatremia (<132mmol/l)
• Severe aortic regurgitation, severe mitral regurgitation, heart failure
• Symptomatic coronary heart disease
• Bradycardic arrhythmia (heart rate < 60/min)
• Peripheral artery occlusive disease (clinical stadium II-IV)
• Dilatative arteriopathy, history of subarachnoidal bleeding
• Decompensated arterial hypertension (Blood pressure >160/100mmHg despite intensive treatment)
• Present or suspected acute mesenteric ischemia
• Septic shock
• Pregnancy

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl	Placebo	Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours).
Terlipressin	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).

Primary Outcome Measures

Name	Time	Method
Number of patients with incident of a composite end point	one month

Secondary Outcome Measures

Name	Time	Method
Number of patients with pleural effusion	one month
Number of patients with surgical site infection	one month
Number of patients with sepsis	one month
Number of patients with pneumonia	one month
Number of patients with intraabdominal hematoma	one month
Number of patients with acute renal failure	one month
Number of patients with blood transfusion	one month

Trial Locations

Locations (1)

Dep. of Visceral Surgery, University Hospital Berne; 🇨🇭 Berne, Switzerland