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

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ClinicalTrials.gov Identifier: NCT00708747
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : July 2, 2008
Sponsor:
Information provided by:
Medical University of Vienna

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Systemic Inflammatory Response Syndrome Drug: Albumin (5% serum-protein solution containing immunoglobulins) Drug: Biseko Phase 4

Detailed Description:

Out of 40 patients randomised, 18 patients received albumin, 20 patients received Biseko and 2 patients died before receiving the complete study medication. During days 1-6 of the study period, serum-levels of IL-1ß were significantly lower in patients with Biseko-therapy compared to patients receiving albumin (IL-1ß-Area under the curve 65.04 ± 71.09 days.pg/ml and 111.05 ± 156.97 days.pg/ml respectively, P=0.03). No difference could be found in serum-levels of IL-6, TNF-α and TNF-R between both groups. While a statistically not significant trend towards better survival was observed in the Biseko-group on day 28, the survival rate on day 180 was significantly higher in the Biseko-group [9/18 (50%)] vs. albumin- group [2/20 (10%), (P=0.008)].

Conclusion: Data suggest that Biseko treatment was associated with significantly lower IL-1ß plasma concentrations (d1 to 6) and improved long-term survival rates.

The data provided in our study are the first to be collected in a randomized, controlled trial. Certainly, the small number of patients and the variety of diseases limit our study, however, the variety of diseases reflects the realistic large scale of morbidity in the medical intensive care unit.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Biseko Versus Albumin in the Treatment of High Risk Patients With Systemic Inflammatory Response Syndrome - a Randomized Controlled Trial
Study Start Date : July 1996
Actual Primary Completion Date : June 2001
Actual Study Completion Date : September 2003
Arms and Interventions
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Arm Intervention/treatment
Experimental: B
Patients were randomised to receive a commercially available standardised 5% serum-protein solution (Biseko, Biotest, Dreieich, Germany) containing all important transport and inhibitor proteins as well as immunoglobulins
 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.
Active Comparator: A
Patients were randomised to receive a 5% albumin solution
 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.
Other Name: Albumin


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. The secondary aim is to evaluate survival of the patients. [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged between 18 and 85 years fulfilling at least two of the four SIRS criteria:

    • body temperature > 38°C or < 36°C
    • tachycardia > 90/min
    • tachypnea > 20/min with spontaneous respiration
    • leucocytosis > 12,000/mcl
    • leucopenia < 4,000/mcl or more than 10 % immature granulocytes were included [8,21,22]

Exclusion Criteria:

  • Patients with proven intolerance against homologous protein solutions
  • Patients with known liver failure
  • Pregnant patients
  • Patients with absolute IgA deficiency were excluded
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708747


Locations
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Austria
Medical University Vienna
Vienna, Austria, A1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Michael Frass, MD Medical University Vienna
More Information
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Publications:

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Responsible Party: Michael Frass, Medical University Vienna
ClinicalTrials.gov Identifier: NCT00708747    
Other Study ID Numbers: 2340
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: July 2, 2008
Last Verified: July 2008
Keywords provided by Medical University of Vienna:
Immunoglobulins
inhibitor proteins
human albumin
 systemic inflammatory response syndrome
interleukins
standardized serum-protein solution
Additional relevant MeSH terms:
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Syndrome
Systemic Inflammatory Response Syndrome
Disease
Pathologic Processes
Inflammation
Shock
 Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunologic Factors
Physiological Effects of Drugs