Status:
COMPLETED
Biseko Versus Albumin in Systemic Inflammatory Response Syndrome (SIRS) Patients
Lead Sponsor:
Medical University of Vienna
Conditions:
Systemic Inflammatory Response Syndrome
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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...
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-...
Eligibility Criteria
Inclusion
- 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
- Patients with proven intolerance against homologous protein solutions
- Patients with known liver failure
- Pregnant patients
- Patients with absolute IgA deficiency were excluded
Key Trial Info
Start Date :
July 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00708747
Start Date
July 1 1996
End Date
September 1 2003
Last Update
July 2 2008
Active Locations (1)
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1
Medical University Vienna
Vienna, Austria, A1090