Liver Failure, Liver Resection
Conditions
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
Interventions
DRUGTerlipressin
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).
DRUGPlacebo
Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours).
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with incident of a composite end point | one month |
Secondary
| Measure | Time frame |
|---|---|
| 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 pleural effusion | one month |
| Number of patients with acute renal failure | one month |
| Number of patients with blood transfusion | one month |
| Number of patients with intraabdominal hematoma | one month |
Countries
Switzerland
Outcome results
None listed