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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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16 December 2017 |
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Main ID: |
NCT02237833 |
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Date of registration:
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08/09/2014 |
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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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Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study
CONSCIOUS |
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Scientific title:
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Cerebral Oxygenation in Septic Patients Using Vasopressors - The Conscious Study |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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15 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02237833 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Norway
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Contacts
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Name:
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Karl-Andre Wian, cand.med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Syekhuset Vestfold HF |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years or older
- Septic shock patients in ICU department requiring vasopressor therapy
Exclusion Criteria:
- Damage to the frontal lobes corresponding to the area where SCO2 is monitored
- Patients in pharmacological studies
- Patients with known intracranial vascular anomalies or cerebral aneurysms
- Patients where vasoactive medication is started before cerebral oxymetry is
established
- Patients with known neurological disease
- Patients with undergone cerebral insult, transient ischemic attack or carotid stenosis
- Patients who have been resuscitated after cardiac arrest in connection with this
hospital stay
- Patients with a body temperature below 35 degrees Celsius when establishing monitoring
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Septic Shock
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Primary Outcome(s)
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Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Fluid balance
[Time Frame: 24 hours]
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Incidence of organ failure
[Time Frame: Discharge from ICU, expected 5 days at average]
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Length of stay in hospital
[Time Frame: Discharge from hospital, expected 10 days at average]
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Length of stay in ICU
[Time Frame: Discharge from ICU, expected 5 days at average]
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Incidence of acute myocardial infarction
[Time Frame: Hospital discharge, expected 12 days at average]
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Use of vasopressors/inotropes
[Time Frame: Discharge from ICU, expected 5 days at average]
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Secondary ID(s)
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2014/194 REK
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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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