FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-007989-34-IT
Enrollment
Unknown
Registered
2009-02-23
Start date
2009-09-09
Completion date
Unknown
Last updated
2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis in cirrhotic patients. MedDRA version: 9.1 Level: PT Classification code 10019641 MedDRA version: 9.1 Level: PT Classification code 10053840

Interventions

Trade Name: PENTAGLOBIN Pharmaceutical Form: Solution for infusion INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm. Concentration unit: mg/ml milligram(s)/millilitre Concentr

Sponsors

AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026