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

NCT ID: NCT00708747

Last Updated: 2008-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-07-31
• Study Completion Date: 2003-09-30

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.

Conditions

Systemic Inflammatory Response Syndrome

Keywords

Immunoglobulins; inhibitor proteins; human albumin; systemic inflammatory response syndrome; interleukins; standardized serum-protein solution

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Biseko

Intervention Type: DRUG

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

Patients were randomised to receive a 5% albumin solution

Group Type: ACTIVE_COMPARATOR

Albumin (5% serum-protein solution containing immunoglobulins)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Albumin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Medical University Vienna

Principal Investigators

Michael Frass, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Locations

Medical University Vienna

Vienna, , Austria

Countries

Austria

References

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. doi: 10.1097/01.ccm.0000142984.44321.a4.

Reference Type: BACKGROUND

PMID: 15542955 (View on PubMed)

Other Identifiers

2340

Identifier Type: -

Identifier Source: org_study_id