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

Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Systemic Inflammatory Response Syndrome

Intervention: Albumin (5% serum-protein solution containing immunoglobulins) (Drug); Biseko (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Michael Frass, MD, Principal Investigator, Affiliation: Medical University Vienna

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: 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-1 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.

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Medical University Vienna, Vienna A1090, Austria
Additional Information

Related 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. Review.

Starting date: July 1996
Last updated: July 1, 2008

Page last updated: August 23, 2015

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