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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • The secondary aim is to evaluate survival of the patients. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: July 1996
Study Completion Date: September 2003
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Biseko
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708747

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

Publications:
Responsible Party: Michael Frass, Medical University Vienna
ClinicalTrials.gov Identifier: NCT00708747     History of Changes
Other Study ID Numbers: 2340
Study First Received: June 26, 2008
Last Updated: July 1, 2008
Health Authority: Austria: Agency for Health and Food Safety

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:
Systemic Inflammatory Response Syndrome
Syndrome
Inflammation
Pathologic Processes
Shock
Disease
Pharmaceutical Solutions
Immunoglobulins
Antibodies
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014