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Terlipressin Administration in Patients Undergoing Major Liver Resection

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ClinicalTrials.gov Identifier: NCT01921985
Recruitment Status : Terminated (Interim analysis revealed that no statistical difference will be identified after inclusion of the patient cohort as foreseen in the sample size calculation)
First Posted : August 14, 2013
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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

Condition or disease Intervention/treatment Phase
Liver Resection Liver Failure Drug: Terlipressin Drug: Placebo Phase 2

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Terlipressin Administration in Patients Undergoing Major Liver Resection: a Prospective Randomized Blinded Trial
Study Start Date : November 2013
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Arm Intervention/treatment
Active Comparator: 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).
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).

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




Primary Outcome Measures :
  1. Number of patients with incident of a composite end point [ Time Frame: one month ]

Secondary Outcome Measures :
  1. Number of patients with pleural effusion [ Time Frame: one month ]
  2. Number of patients with surgical site infection [ Time Frame: one month ]
  3. Number of patients with sepsis [ Time Frame: one month ]
  4. Number of patients with pneumonia [ Time Frame: one month ]
  5. Number of patients with intraabdominal hematoma [ Time Frame: one month ]
  6. Number of patients with acute renal failure [ Time Frame: one month ]
  7. Number of patients with blood transfusion [ Time Frame: one month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921985


Locations
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Switzerland
Dep. of Visceral Surgery, University Hospital Berne
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Guido Beldi, Professor Dr. med. University of Bern

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01921985     History of Changes
Other Study ID Numbers: 190/11
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Terlipressin
Antihypertensive Agents
Vasoconstrictor Agents