se of policlonal immunoglobulins (Pentaglobin) in the treatment of sepsis in cirrhotic patients awaiting for liver transplantation. - Pentaglobin in cirrhotic patients.

Conditions: Sepsis in cirrhotic patients.
MedDRA version: 9.1Level: PTClassification code 10019641
MedDRA version: 9.1Level: PTClassification code 10053840

Registration Number: EUCTR2008-007989-34-IT

Lead Sponsor: AZIENDA OSPEDALIERA POLICLINICO DI MODENA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Cirrhotic patients, 18-70 years of age, awaiting liver trasplantation, with or without hepatocellular carcinoma, consecutively seen at the Transplant Surgery Unit with sepsis.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with HIV infection, patients with digestive bleending in 5 days before the enrollment; pz already in antibiotic terapy; pz with know hypersensitivity to immunoglobulin.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate if pentaglobin use in cirrhotic patients with sepsis awaiting liver transplantation improve the clinical status and allow the maintainace of the clinical parameters to liver transplantation.;Secondary Objective: - To evaluate whether the use of Pentaglobin in association with antibiotic therapy can decrease morbidity and mortality in cirrhotic patients awaiting liver transplantation, estimating survival at 30 and 60 days from sepsis onset. - To evaluate whether Pentaglobin use reduces the timing for negativization of cultures and antibiotic exposure. - To study the correlation between use of Pentaglobin and some parameters such as Procalcitonin, Reactive C Protein, endotoxemia and SOFA score.;Primary end point(s): - To increase the number of patients who recovery the clinical criteria for liver transplantation; - To decrease complications of sepsis and mortality for sepsis.

Secondary Outcome Measures