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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00708747
First received: June 26, 2008
Last updated: July 1, 2008
Last verified: July 2008

June 26, 2008
July 1, 2008
July 1996
June 2001   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00708747 on ClinicalTrials.gov Archive Site
The secondary aim is to evaluate survival of the patients. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Biseko Versus Albumin in Systemic Inflammatory Response Syndrome (SIRS) Patients
Biseko Versus Albumin in the Treatment of High Risk Patients With Systemic Inflammatory Response Syndrome - a Randomized Controlled Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Systemic Inflammatory Response Syndrome
  • 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
  • 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.
    Other Name: Biseko
  • 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
    Intervention: Drug: Biseko
  • Active Comparator: A
    Patients were randomised to receive a 5% albumin solution
    Intervention: Drug: Albumin (5% serum-protein solution containing immunoglobulins)
Vincent JL, Gerlach H. Fluid resuscitation in severe sepsis and septic shock: an evidence-based review. Crit Care Med. 2004 Nov;32(11 Suppl):S451-4. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2003
June 2001   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00708747
2340
No
Michael Frass, Medical University Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Michael Frass, MD Medical University Vienna
Medical University of Vienna
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP