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Biseko Versus Albumin in Systemic Inflammatory Response Syndrome (SIRS) Patients

NCT00708747 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2008-07-02

No results posted yet for this study

Summary

Morbidity and mortality in patients suffering from systemic inflammatory response syndrome (SIRS) remain high. The primary aim of the present study is to assess the efficacy of a standardized 5% serum-protein solution containing immunoglobulins on serum cytokine levels. The secondary aim is to evaluate survival of the patients.

Conditions

  • Systemic Inflammatory Response Syndrome

Interventions

DRUG

Albumin (5% serum-protein solution containing immunoglobulins)

5% albumin was given intravenously at a volume of 1,000 ml on the first day and 500 ml/day during the following four days.

DRUG

Biseko

Standardised 5% serum-protein solution (Biseko, Biotest, Dreieich, Germany) was given intravenously at a volume of 1,000 ml on the first day and 500 ml/day during the following four days.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Michael Frass, MD · Medical University Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-07-31
Primary Completion
2001-06-30
Completion
2003-09-30

Countries

  • Austria

Study Locations

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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 NCT00708747 on ClinicalTrials.gov