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NCT Number: NCT00708747

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

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.

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Key information

Conditions

Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Vienna

Vienna, A1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albumin (5% serum-protein solution containing immunoglobulins)

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.

Other names: Albumin

Biseko

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. The secondary aim is to evaluate survival of the patients.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
1996
Primary completion
2001
Study completion
2003
First posted
Jul 2, 2008
Registry last updated
Jul 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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