Biseko Versus Albumin in Systemic Inflammatory Response Syndrome (SIRS) Patients
|Systemic Inflammatory Response Syndrome||Drug: Albumin (5% serum-protein solution containing immunoglobulins) Drug: Biseko||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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|
- 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 ]
- The secondary aim is to evaluate survival of the patients. [ Time Frame: 3 years ]
|Study Start Date:||July 1996|
|Study Completion Date:||September 2003|
|Primary Completion Date:||June 2001 (Final data collection date for primary outcome measure)|
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
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708747
|Medical University Vienna|
|Vienna, Austria, A1090|
|Principal Investigator:||Michael Frass, MD||Medical University Vienna|