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

Phase 4

Completed

• Conditions: Systemic Inflammatory Response Syndrome
• Interventions: Drug: Biseko; Drug: Albumin (5% serum-protein solution containing immunoglobulins)

• Registration Number: NCT00708747
• Lead Sponsor: Medical University of Vienna

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.

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 Timeline

• Study Start: 1996-07
• Primary Completion: 2001-06
• Study Completion: 2003-09
• Study First Submitted: 2008-06-26
• Status Verified: 2008-07
• Study First Submitted QC: 2008-07-01
• Last Update Submitted: 2008-07-01
• Study First Posted: 2008-07-02
• Last Update Posted: 2008-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Biseko	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
A	Albumin (5% serum-protein solution containing immunoglobulins)	Patients were randomised to receive a 5% albumin solution

Primary Outcome Measures

Name	Time	Method
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.	3 years

Secondary Outcome Measures

Name	Time	Method
The secondary aim is to evaluate survival of the patients.	3 years

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria