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

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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Inflammatory Response Syndrome
• Intervention / Treatment: Drug: Biseko; Drug: Albumin (5% serum-protein solution containing immunoglobulins)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A1090
    • Medical University Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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.
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 Names: Albumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
The secondary aim is to evaluate survival of the patients.	3 years

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Michael Frass, MD, Medical University Vienna

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start: July 1, 1996
• Primary Completion (ACTUAL): June 1, 2001
• Study Completion (ACTUAL): September 1, 2003

Study Registration Dates

• First Submitted: June 26, 2008
• First Submitted That Met QC Criteria: July 1, 2008
• First Posted (ESTIMATE): July 2, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 2, 2008
• Last Update Submitted That Met QC Criteria: July 1, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: systemic inflammatory response syndrome; Immunoglobulins; human albumin; interleukins; inhibitor proteins; standardized serum-protein solution
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Disease; Shock; Syndrome; Systemic Inflammatory Response Syndrome; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: 2340