Terlipressin Administration in Patients Undergoing Major Liver Resection

NCT01921985 | Terminated Phase 2 DMC

• 1 other identifier: 190/11
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Resection; Liver Failure

Outcome Measures

Primary Outcomes (1)

• Number of patients with incident of a composite end point

  one month

Secondary Outcomes (7)

• Number of patients with pleural effusion

  one month

• 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 intraabdominal hematoma

  one month

Study Arms (2)

Terlipressin

ACTIVE COMPARATOR

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

NaCl

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Terlipressin 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).

Terlipressin

Placebo DRUG

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

NaCl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing resection of 3 or more liver segments
• Minimum age of 18
• Any gender
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Visceral Surgery, University Hospital Berne

Bern, 3010, Switzerland

Location

Related Publications (1)

• Kohler A, Perrodin S, De Gottardi A, Candinas D, Beldi G. Effectiveness of terlipressin for prevention of complications after major liver resection - A randomized placebo-controlled trial. HPB (Oxford). 2020 Jun;22(6):884-891. doi: 10.1016/j.hpb.2019.10.011. Epub 2019 Oct 31.

  PMID: 31680011 DERIVED

MeSH Terms

Conditions

Liver Failure

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Guido Beldi, Professor Dr. med.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 14, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

CH (1)