Immunoadsorption of LPS, C5a and IL-6 in Severe Sepsis and Septic Shock (ISASS-1)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00146432
• Date of registration: 06/09/2005
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Immunoadsorption of LPS, C5a and IL-6 in Severe Sepsis and Septic Shock (ISASS-1)
• Scientific title: Prospective, Controlled Pilot Trial: Treatment of Patients in Severe Sepsis and Septic Shock With Immunoadsorption of LPS, IL-6, C5a
• Date of first enrolment: March 2004
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00146432
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Germany

Contacts

• Name: Petra Reinke, MD, PhD
• Affiliation: Charite, University Medicine Berlin, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of severe sepsis or septic shock (ACCP/SCCM)

- Presence of 4 SIRS criteria/indicators

- Suspected or proven infection (refer also to: 1.)

- Age 18-80

- APACHE II score > 18

- At least one acute organ dysfunction (renal/pulmonary/hemodynamics/cerebral)

Exclusion Criteria:

- Suspected or proven pregnancy

- Absolute contraindication for anticoagulation (active bleeding)

- Absolute IgA-deficiency

- History of anaphylactic reaction to egg-albumin

- Participants in other clinical trials (<12 wks. prior to study inclusion)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Septicemia

Intervention(s)

Procedure: Immunoadsorption of LPS, IL-6 and C5a

Secondary ID(s)

ISASS-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

adexter GmbH

German Research Foundation