Terlipressin Administration in Patients Undergoing Major Liver Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2018-03-31

Brief Summary

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

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Detailed Description

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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

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Liver Resection Liver Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

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).

NaCl

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No