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

NCT00708747 | Completed Phase 4

• 1 other identifier: 2340
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Inflammatory Response Syndrome

Keywords

Immunoglobulins; inhibitor proteins; human albumin; systemic inflammatory response syndrome; interleukins; standardized serum-protein solution

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (1)

• The secondary aim is to evaluate survival of the patients.

  3 years

Study Arms (2)

B

EXPERIMENTAL

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

A

ACTIVE COMPARATOR

Patients were randomised to receive a 5% albumin solution

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

Interventions

Albumin (5% serum-protein solution containing immunoglobulins) DRUG

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.

Also known as: Albumin

A

Biseko DRUG

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.

B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[8,21,22\]

You may not qualify if:

• Patients with proven intolerance against homologous protein solutions
• Patients with known liver failure
• Pregnant patients
• Patients with absolute IgA deficiency were excluded

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, A1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 15542955 BACKGROUND

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Interventions

Albumins

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Michael Frass, MD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: July 2, 2008
• Study Start: July 1, 1996
• Primary Completion: June 1, 2001
• Study Completion: September 1, 2003
• Last Updated: July 2, 2008

Record last verified: 2008-07

Locations

AU (1)