Biseko Versus Albumin in Systemic Inflammatory Response Syndrome (SIRS) Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00708747 |
Recruitment Status :
Completed
First Posted : July 2, 2008
Last Update Posted : July 2, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Inflammatory Response Syndrome | Drug: Albumin (5% serum-protein solution containing immunoglobulins) Drug: Biseko | Phase 4 |
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 (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Biseko Versus Albumin in the Treatment of High Risk Patients With Systemic Inflammatory Response Syndrome - a Randomized Controlled Trial |
Study Start Date : | July 1996 |
Actual Primary Completion Date : | June 2001 |
Actual Study Completion Date : | September 2003 |
Arm | Intervention/treatment |
---|---|
Experimental: B
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
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. |
Active Comparator: A
Patients were randomised to receive a 5% albumin solution
|
Drug: Albumin (5% serum-protein solution containing immunoglobulins)
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.
Other Name: Albumin |
- 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 ]
- The secondary aim is to evaluate survival of the patients. [ Time Frame: 3 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708747
Austria | |
Medical University Vienna | |
Vienna, Austria, A1090 |
Principal Investigator: | Michael Frass, MD | Medical University Vienna |
Responsible Party: | Michael Frass, Medical University Vienna |
ClinicalTrials.gov Identifier: | NCT00708747 |
Other Study ID Numbers: |
2340 |
First Posted: | July 2, 2008 Key Record Dates |
Last Update Posted: | July 2, 2008 |
Last Verified: | July 2008 |
Immunoglobulins inhibitor proteins human albumin |
systemic inflammatory response syndrome interleukins standardized serum-protein solution |
Syndrome Systemic Inflammatory Response Syndrome Disease Pathologic Processes Inflammation Shock |
Immunoglobulins Immunoglobulins, Intravenous Antibodies Immunologic Factors Physiological Effects of Drugs |