Terlipressin Administration in Patients Undergoing Major Liver Resection

Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01921985
• Other study ID #: 190/11
• Status: Terminated
• Phase: Phase 2
• First received: August 9, 2013
• Last updated: March 26, 2018
• Start date: November 2013
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Failure
• Liver Resection

Intervention

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).
• Placebo
Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours).

Locations

Country	Name	City	State
Switzerland	Dep. of Visceral Surgery, University Hospital Berne	Berne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with incident of a composite end point		one month
Secondary	Number of patients with pleural effusion		one month
Secondary	Number of patients with surgical site infection		one month
Secondary	Number of patients with sepsis		one month
Secondary	Number of patients with pneumonia		one month
Secondary	Number of patients with intraabdominal hematoma		one month
Secondary	Number of patients with acute renal failure		one month
Secondary	Number of patients with blood transfusion		one month