Biseko Versus Albumin in Systemic Inflammatory Response Syndrome (SIRS) Patients - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00708747

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 IV

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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
B: Experimental 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.
A: Active Comparator 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.

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

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:

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.

Responsible Party:	Medical University Vienna ( Michael Frass )
Study ID Numbers:	2340
Study First Received:	June 26, 2008
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00708747
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

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Antibodies
Shock
Immunoglobulins
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Disease
Immunologic Factors

Syndrome
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009