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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00167596 |
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Date of registration:
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09/09/2005 |
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Primary sponsor: |
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Public title:
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Near Infrared Spectroscopy (NIRS) in Severe Sepsis
OTO-STS |
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Scientific title:
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Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis |
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Date of first enrolment:
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July 2005 |
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Target sample size:
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101 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00167596 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Germany
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Greece
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Spain
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Contacts
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Name:
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Djillali Annane, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Raymond Poincaré Hospital, AP-HP |
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Name:
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Gwenhael Colin, 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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Raymond Poincaré Hospital, AP-HP |
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Name:
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Olivier Nardi, 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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Raymond Poincaré Hospital, AP-HP |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Two of four criteria for the systemic inflammatory response syndrome; and one of the
following:
- systolic blood pressure =< 90 mm Hg; or
- a blood lactate concentration => 4 mmol/l; or
- skin marbling; or
- impaired consciousness; or
- urine output < 30 ml/h.
Exclusion Criteria:
- Age < 18 years
- Pregnancy
- Do-not-resuscitate status
- Advanced directives restricting implementation of the protocol
- Obesity (body mass index [BMI] > 30)
- Anasarca
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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Critical Illness
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Severe Sepsis
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Intervention(s)
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Device: conventional
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Device: Near Infrared Spectroscopy
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Primary Outcome(s)
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A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint
[Time Frame: Day 7]
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Secondary Outcome(s)
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duration of mechanical ventilation
[Time Frame: from randomization to Day 28]
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length of the hospital stay
[Time Frame: from randomization to Day 90]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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