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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 1

Conditions: Liver Transplant With Clinically Significant Portal Hypertension

Treatments: Drug: Administration of Somatostatin; Drug: Administration of placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01290172

2008-008319-24 (EudraCT Number)

2008/689

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

33 participants in 2 patient groups, including a placebo group

Somatostatin

Experimental group

Description:

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

Treatment:

Drug: Administration of Somatostatin

Placebo

Placebo Comparator group

Description:

Patients in this group receive a placebo for 5 days.

Treatment:

Drug: Administration of placebo