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

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; Pharmaceutical Solutions

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