Clinical trial NCT00708747: Biseko Versus Albumin in Systemic Inflammatory Response Syndrome (SIRS) Patients
Official title: Biseko Versus Albumin in the Treatment of High Risk Patients With Systemic Inflammatory Response Syndrome - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Systemic Inflammatory Response Syndrome
Keywords: Immunoglobulins
inhibitor proteins
human albumin
systemic inflammatory response syndrome
interleukins
standardized serum-protein solution
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-07-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-protein solution containing immunoglobulins on serum cytokine levels. 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-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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: The secondary aim is to evaluate survival of the patients.
timeFrame: 3 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University Vienna
name: Michael Frass, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/01.ccm.0000142984.44321.a4.