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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00527007 |
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Date of registration:
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06/09/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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External Cooling in Septic Shock Patients
sepsis-cool |
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Scientific title:
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Impact of External Cooling in Septic Shock Patients |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00527007 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Frederique SCHORTGEN, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Documented or suspected infection
- Body temperature > 38.3°C
- Persistent hypotension despite fluid resuscitation and need for vasopressor infusion
to maintain mean arterial pressure > 65 mmHg.
- Invasive mechanical ventilation
- Intravenous sedation
Exclusion Criteria:
- Temperature > 41°C
- Age < 18 years
- Pregnancy
- Continuous renal replacement therapy
- Paracetamol or NSAI administration within 6 hours before inclusion
- Need for paracetamol and/or NSAI therapy during the study period
- Burns or Lyell syndrome
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Septic Shock
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Intervention(s)
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Other: External cooling
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Primary Outcome(s)
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Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment
[Time Frame: 48 hours after enrolment]
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Secondary Outcome(s)
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Number of vasopressor free days in the ICU
[Time Frame: during the study]
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SOFA score evolution
[Time Frame: on Day 3, Day 7, Day 14]
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Maximal dose of vasopressors
[Time Frame: within 48 hours after enrolment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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