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Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study (CONSCIOUS)

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ClinicalTrials.gov Identifier: NCT02237833
Recruitment Status : Terminated (Too slow recruitment.)
First Posted : September 11, 2014
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Karl-Andre Wian, Sykehuset i Vestfold HF

Brief Summary:
The purpose of this study is to reveal if higher doses of vasopressors in septic shock patients correlates with cerebral vasoconstriction and lower cerebral oximetry.

Condition or disease
Septic Shock

Detailed Description:
The mortality with septic shock is high. Treatment includes antibiotics, intravenous fluid and drugs for circulatory support, especially the vasopressor norepinephrine. Fluids and drugs for circulatory support are to restore adequate organ perfusion. Inadequate oxygenation of the brain can give neurologic damage. Traditionally treatment is guided by surrogate markers like arterial and central venous pressure. Cerebral oximetry is a non-invasive method which measures cerebral saturation of oxygen, SCO2, and thereby expresses regional cerebral perfusion. By registering cerebral oxymetry on patients treated with vasopressors for septic shock we want to reveal if higher doses of vasopressor correlates with cerebral vasoconstriction and lower cerebral oximetry.

Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Oxygenation in Septic Patients Using Vasopressors - The Conscious Study
Study Start Date : February 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort
Septic shock and vasopressor
Measuring cerebral oxymetry (SCO2) first 24 hours in septic shock and given vasopressors.



Primary Outcome Measures :
  1. Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours [ Time Frame: 24 hours ]
    SCO2 will be measured before initiating vasopressor therapy. Thereafter SCO2 are updated every 2 seconds and is measured for 24 hours.


Secondary Outcome Measures :
  1. Incidence of acute myocardial infarction [ Time Frame: Hospital discharge, expected 12 days at average ]
    Incidence of acute myocardial infarction based on international criteria

  2. Use of vasopressors/inotropes [ Time Frame: Discharge from ICU, expected 5 days at average ]

    Use of vasopressors/inotropes

    • norepinephrine
    • epinephrine
    • dopamine
    • dobutamine
    • vasopressin
    • nitroprusside
    • glyceryltrinitrate

  3. Fluid balance [ Time Frame: 24 hours ]
  4. Length of stay in ICU [ Time Frame: Discharge from ICU, expected 5 days at average ]
  5. Length of stay in hospital [ Time Frame: Discharge from hospital, expected 10 days at average ]
  6. Incidence of organ failure [ Time Frame: Discharge from ICU, expected 5 days at average ]
    Measuring Sequential Organ Failure Assessment, SOFA, score at inclusion and once daily during ICU-stay.


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in the intensive care unit needing vasopressor for septic shock.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237833


Locations
Norway
Sykehuset i Vestfold HF
Tonsberg, Vestfold, Norway, N-3117
Sponsors and Collaborators
Karl-Andre Wian
Investigators
Principal Investigator: Karl-Andre Wian, cand.med. Syekhuset Vestfold HF

Responsible Party: Karl-Andre Wian, MD, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT02237833     History of Changes
Other Study ID Numbers: 2014/194 REK
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Karl-Andre Wian, Sykehuset i Vestfold HF:
septic shock
cerebral oximetry
vasopressor
norepinephrine

Additional relevant MeSH terms:
Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Vasoconstrictor Agents