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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01290172
First received: February 3, 2011
Last updated: February 1, 2013
Last verified: February 2013

February 3, 2011
February 1, 2013
December 2010
September 2013   (final data collection date for primary outcome measure)
Evaluation of safety and efficacy using Somatostatin. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01290172 on ClinicalTrials.gov Archive Site
  • To elucidate pathophysiological pathways in non-cirrhotic grafted livers. [ Time Frame: 35 days ] [ Designated as safety issue: No ]
  • To evaluate the reduction of ischemia-reperfusion injury (cytoprotective effect) [ Time Frame: 1 hour after reperfusion and 5 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To elucidate pathophysiological pathways in non-cirrhotic grafted livers. [ Time Frame: 35 days ] [ Designated as safety issue: No ]
  • To evaluate the reduction of ischemia-reperfusion injury (cytoprotective effect) [ Time Frame: after 5 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.
A Single-center, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Liver Transplant With Clinically Significant Portal Hypertension
  • 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.

  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
33
December 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Roberto Troisi, PhD, MD Roberto.Troisi@ugent.be
Belgium
 
NCT01290172
2008/689, 2008-008319-24
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Roberto Troisi, PhD, MD University Hospital, Ghent
University Hospital, Ghent
February 2013

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