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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Systemic Inflammatory Response Syndrome

Intervention / Treatment
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* Drug: Albumin (5% serum-protein solution containing immunoglobulins)
* Drug: Biseko


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B<br>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<br>* 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.<br>|
| Active Comparator: A<br>Patients were randomised to receive a 5% albumin solution | Drug: Albumin (5% serum-protein solution containing immunoglobulins)<br>* 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.<br>* Other names: Albumin;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunoglobulins, inhibitor proteins, human albumin, systemic inflammatory response syndrome, interleukins, standardized serum-protein solution