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

Systemic Inflammatory Response Syndrome Clinical Trial

Official title:

Biseko Versus Albumin in the Treatment of High Risk Patients With Systemic Inflammatory Response Syndrome - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708747
• Other study ID #: 2340
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2008
• Last updated: July 1, 2008
• Start date: July 1996
• Est. completion date: September 2003

Study information

• Verified date: July 2008
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2003
• Est. primary completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syndrome
• Systemic Inflammatory Response Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The secondary aim is to evaluate survival of the patients.		3 years	Yes