Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01290172

First Posted: February 4, 2011

Last Update Posted: December 2, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

University Hospital, Ghent

Tracking Information

First Submitted Date ^ICMJE

February 3, 2011

First Posted Date ^ICMJE

February 4, 2011

Last Update Posted Date

December 2, 2014

Start Date ^ICMJE

December 2010

Primary Completion Date

December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluation of safety and efficacy using Somatostatin. [ Time Frame: 5 days ]

To evaluate the safety and efficacy, using Somatostatin as portal vein flow and pressure modulator in liver transplantation in humans. Hepatic and systemic hemodynamic measurements will be recorded prior, during and after the bolus infusion of Somatostatin/Placebo during liver transplantation. Infusion of Somatostatin/Placebo will be continued for 5 days.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01290172 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To elucidate pathophysiological pathways in non-cirrhotic grafted livers. [ Time Frame: 35 days ]
To evaluate the reduction of ischemia-reperfusion injury (cytoprotective effect) [ Time Frame: 1 hour after reperfusion and 5 days ]
To evaluate the efficacy of Somatostatin in the prevention of the small-for-size syndrome (SFSS) in partial liver transplantation. [ Time Frame: after 35 days ]

Original Secondary Outcome Measures ^ICMJE

To elucidate pathophysiological pathways in non-cirrhotic grafted livers. [ Time Frame: 35 days ]
To evaluate the reduction of ischemia-reperfusion injury (cytoprotective effect) [ Time Frame: after 5 days ]
To evaluate the efficacy of Somatostatin in the prevention of the small-for-size syndrome (SFSS) in partial liver transplantation. [ Time Frame: after 35 days ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.

Official Title ^ICMJE

A Single-center, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.

Brief Summary

This study is a 5 day, single-center, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of Somatostatin used as inflow modulator in liver transplantation. Patient systemic and hepatic dynamics will be collected and recorded at predefined time-points. To evaluate the ischemia-reperfusion injury, it is planned to perform liver biopsies at two different time-points to compare the liver structure and proteomic variations.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Liver Transplant With Clinically Significant Portal Hypertension

Intervention ^ICMJE

Drug: Administration of Somatostatin
6 mg will be diluted in saline in a 60 cc syringe to be infused over 24 h (250 mcg/h). The treatment will be started during the hepatectomy phase, after 1st measurement of native arterial and portal flow and pressure and given a clinically significant portal hypertension (CSPH) with a hepatic venous pressure gradient (HVPG) >= 10 mmHg.

5 cc will be injected in 2 minutes as a single bolus of 500 mcg. Somatostatin will be given a second time at the beginning of the warm ischemia time as a continuous infusion of 250 mcg/h(infusion rate 2,5 cc/h). This will allow the time needed for reaching a stable plasma concentration at reperfusion and minimizing risks of secondary effects. After portal revascularization of the liver graft, a new measurement of portal flow and pressure will be performed. Provided a portal vein flow (PVF) >= 90 ml/min * 100 g LW, the remaining 55 cc will be infused for the following 22 h. 6 mg per day of continuous infusion will be continued for 5 days.
Drug: Administration of placebo
The placebo treatment will be started during the hepatectomy phase, after the 1st measurement of native arterial and portal flow and pressure and given a clinically significant portal hypertension (CSPH) with a hepatic venous pressure gradient (HVPG) >= 10 mmHg.

5 cc of the 60 cc solution will be injected in 2 minutes as a single bolus of 500 mcg. The placebo will be given a 2nd time at the beginning of the warm ischemia time as a continuous infusion of 250 mcg/h (infusion rate 2,5 cc/h). This will allow the time needed for reaching a stable plasma concentration at reperfusion and minimizing risks of secondary effects. After portal revascularization of the liver graft, a new measurement of portal flow and pressure will be performed. Provided a portal vein flow (PVF) >= 90 ml/min * 100 gram LW, the remaining 55 cc will be infused for the following 22 h. 6 mg per day of continuous infusion will be continued everyday to complete 5 days of therapy.

Study Arms

Experimental: Somatostatin
Patients in this group receive treatment with Somatostatin for 5 days.

Intervention: Drug: Administration of Somatostatin
Placebo Comparator: Placebo
Patients in this group receive a placebo for 5 days.

Intervention: Drug: Administration of placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2014

Primary Completion Date

December 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Ability and willingness to provide written informed consent
Cirrhotic patients with established clinically significant portal hypertension (CSPH) defined as an increase in hepatic venous pressure gradient >= 10 mmHg
Recipients who are 18-70 years of age receiving a primary liver transplant from a brain dead donor or living donor
Whole liver grafts and partial liver grafts can be included

Exclusion Criteria:

Patients who are recipients of multiple solid organ transplants, or have previously received an organ or tissue transplant that may not be completely resolved by thrombectomy
HIV positive patients
Patients with known history of portal thrombosis or diagnosed at the time of transplantation that may not be completely resolved by thrombectomy.
Patients included in the preoperative assessment without a CSPH at the time of the first intraoperative measurement of portal pressure
Patients with low portal perfusion (=< 90 ml/min*100 g of LV) measured at the time of operation. Portal flows above this limit can be excluded in the eventuality that, after infusion, the portal perfusion falls below this limit
Patients with porto-pulmonary hypertension
Patients with known cardiac arrhythmias
Recipients of cardiac-dead donors
Fulminant hepatic failure patients

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 70 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01290172

Other Study ID Numbers ^ICMJE

2008/689
2008-008319-24 ( EudraCT Number )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

University Hospital, Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Roberto Troisi, PhD, MD

University Hospital, Ghent

PRS Account

University Hospital, Ghent

Verification Date

November 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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