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

Primary Purpose

Liver Transplant With Clinically Significant Portal Hypertension

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Administration of Somatostatin

Administration of placebo

About this trial

This is an interventional treatment trial for Liver Transplant With Clinically Significant Portal Hypertension focused on measuring Liver transplant, portal hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital, Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Somatostatin

Placebo

Arm Description

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

Patients in this group receive a placebo for 5 days.

Outcomes

Primary Outcome Measures

Evaluation of safety and efficacy using Somatostatin.

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.

Secondary Outcome Measures

To elucidate pathophysiological pathways in non-cirrhotic grafted livers.

To evaluate the reduction of ischemia-reperfusion injury (cytoprotective effect)

To evaluate the efficacy of Somatostatin in the prevention of the small-for-size syndrome (SFSS) in partial liver transplantation.

Full Information

NCT ID

NCT01290172

First Posted

February 3, 2011

Last Updated

November 27, 2014

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT01290172

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Transplant With Clinically Significant Portal Hypertension

Keywords

Liver transplant, portal hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Somatostatin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients in this group receive a placebo for 5 days.

Intervention Type

Drug

Intervention Name(s)

Administration of Somatostatin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Administration of placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evaluation of safety and efficacy using Somatostatin.

Description

Time Frame

5 days

Secondary Outcome Measure Information:

Title

To elucidate pathophysiological pathways in non-cirrhotic grafted livers.

Time Frame

35 days

Title

To evaluate the reduction of ischemia-reperfusion injury (cytoprotective effect)

Time Frame

1 hour after reperfusion and 5 days

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roberto Troisi, PhD, MD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital, Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Related Info

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

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