A Phase 2 interventional study of Terlipressin and Placebo in Liver Resection and Liver Failure, sponsored by Insel Gruppe AG, University Hospital Bern. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by Insel Gruppe AG, University Hospital Bern · Phase 2, Interventional, and Treatment
This study investigates if the administration of terlipressin reduces complications after major liver surgery.
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
445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.
This study's enrollment of 150 is above the median of 43 across 276 interventional studies indexed under Liver Failure.
Browse Liver Failure studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
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: Terlipressin
Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours).
Drug: Placebo
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 (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours).
Number of patients with incident of a composite end point
Time frame: one month
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
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern