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Somatostatin in Living Donor Liver Transplantation

NCT04107428 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-09-27

No results posted yet for this study

Summary

Aim of the study is to investigate the safety and the efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing Adult-to-Adult living donor liver transplantation (A2ALDLT).

Conditions

  • End Stage Liver DIsease
  • Portal Hypertension

Interventions

DRUG

Somatostatin

A bolus of 5cc of saline containing 500 mcg of somatostatin will be administered intravenously after graft reperfusion (after portal and arterial anastomosis) over a 2 minutes period, followed by a continuous infusion of 250 mcg per hour of somatostatin (infusion rate 2.5 cc/hour) for 10 days.

DRUG

Placebo

A bolus of 5cc of saline will be administered intravenously after graft reperfusion (after portal and arterial anastomosis) over a 2 minutes period, followed by a continuous infusion of 2.5 cc of saline/hour for 10 days.

Sponsors & Collaborators

  • Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy

    collaborator UNKNOWN

  • CEINGE - Biotecnologie Avanzate, Napoli, Italia

    collaborator UNKNOWN

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Principal Investigators

  • Roberto Troisi, MD, PhD · King Faisal Specialist Hospital & Research Center

  • Dieter Broering, MD, PhD · King Faisal Specialist Hospital & Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2020-08-31
Completion
2022-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04107428 on ClinicalTrials.gov