COMbining Plasmafiltration and Adsorption Clinical Trial: efficacy and safety of coupled plasma filtration adsorption for septic shock in the intensive care unit
Completed
- Conditions
- Septic shockInfections and InfestationsOther septicaemia
- Registration Number
- ISRCTN24534559
- Lead Sponsor
- Italian Group for the Evaluation of Interventions in Intensive Care Medicine (GiViTI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 330
Inclusion Criteria
All patients admitted to the ICU in septic shock or that develop septic shock while in the IC
Exclusion Criteria
Patients with any of the following characteristics::
1. Age less than 18 years
2. Pregnancy
3. Cardiopulmonary resuscitation
4. Cerebral coma (Glasgow coma score [GCS] <8 due to organic cerebral diseases, irrespective of their surgical, non-surgical, or trauma origin)
5. Metastatic cancer
6. Presence of relative or absolute contraindications to CPFA
7. Estimated life expectancy less than two weeks
8. Already included in the study
9. Admission from another ICU where the patient has been admitted for more than 24 hours
10. Absence of informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hospital mortality<br><br>Added as of 24/04/2009: <br>Total duration of follow-up: until 90 days after the randomisation of the last patients recruited.
- Secondary Outcome Measures
Name Time Method 1. Mortality within 90 days from randomisation<br>2. New organ failures, assessed by Sequential Organ Failure Assessment (SOFA) score during the ICU stay<br>3. Days not spent in the ICU during the first 30 days from randomisation<br><br>Please note that the method and timepoint of assessment for the outcome measure New organ failures were added as of 24/04/2009.