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

Medical University of Vienna40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Systemic Inflammatory Response Syndrome

Interventions

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.

BisekoDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University Vienna

Vienna, Austria

Outcomes

Primary Outcomes

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

The secondary aim is to evaluate survival of the patients.

Time frame: 3 years

Data from ClinicalTrials.gov

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