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).
Terlipressin Administration in Patients Undergoing Major Liver Resection
Status
Terminated
Phase
Phase 2
Enrollment
150
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
This study investigates if the administration of terlipressin reduces complications after major liver surgery.
Full 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
Interventions
Treatment arms and agents.
DRUG
Placebo
Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours).
Timeline
From registration to results.
First posted
Aug 14, 2013
Study start
Nov 2013
Primary completion
Mar 2018
Study completion
Mar 2018
Results posted
Not reported
Registry updated
Mar 29, 2018
Outcomes
What the study measures.
Primary outcomes
Number of patients with incident of a composite end point
Time frame · one month
Secondary outcomes
Number of patients with pleural effusion
Time frame · one month
Number of patients with surgical site infection
Time frame · one month
Number of patients with sepsis
Time frame · one month
Number of patients with pneumonia
Time frame · one month
Number of patients with intraabdominal hematoma
Time frame · one month
Number of patients with acute renal failure
Time frame · one month
Number of patients with blood transfusion
Time frame · one month
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
Switzerland. Showing up to 24 locations stored in the fast local snapshot.
Dep. of Visceral Surgery, University Hospital Berne
Bern, Switzerland
Publications
Results and literature.
Related trials
More studies on Terlipressin.
NCT IDStudyPhase / statusEnrollmentUpdated
Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study
First Affiliated Hospital, Sun Yat-Sen University · Liver Neoplasms · Postoperative Complications
Not applicable
Completed
161
2026-07
Efficacy Of Bovine Colostrum In The Treatment Of Severe Alcohol-Associated Hepatitis: A Randomized Controlled Trial
Dayanand Medical College and Hospital · Alcoholic Hepatitis
Phase 3
Active, not recruiting
174
2026-07
Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation
Beijing Friendship Hospital · Kidney Transplant · Delayed Graft Function
Not applicable
Active, not recruiting
150
2026-07
Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy
University Hospital, Rouen · Bronchial Endoscopy
Phase 3
Completed
130
2026-06
Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation
Istanbul Medipol University Hospital · Liver Transplantation · Portal Hypertension
Not applicable
Recruiting
50
2026-04
ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.
Assistance Publique - Hôpitaux de Paris · Hemoptysis
Phase 3
Completed
315
2026-04
Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome
Noorik Biopharmaceuticals AG · Hepatorenal Syndrome · Liver Cirrhosis
Phase 2
Active, not recruiting
54
2026-04
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Institute of Liver and Biliary Sciences, India · Acute-on-Chronic Liver Failure (ACLF)
Not applicable
Not yet recruiting
56
2026-03
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Put the record in context.
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