Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.
NCT ID: NCT01290172
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2010-12-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Somatostatin
Patients in this group receive treatment with Somatostatin for 5 days.
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.
Placebo
Patients in this group receive a placebo for 5 days.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Roberto Troisi, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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University Hospital, Ghent
Ghent, , Belgium
Countries
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Related Links
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Related Info
Other Identifiers
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2008-008319-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2008/689
Identifier Type: -
Identifier Source: org_study_id