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TerminatedNCT02237833CONSCIOUSUpdated Apr 27, 2017

Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study

An observational study in Septic Shock, sponsored by Karl-Andre Wian. Terminated at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-27.

Sponsored by Karl-Andre Wian · Observational

Why this study was terminated
Too slow recruitment.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Septic Shock

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Keywords

  • septic shock
  • cerebral oximetry
  • vasopressor
  • norepinephrine
03

In context

Shock, Septic

890 studies on the registry are indexed under Shock, Septic; 210 are open to participants now.

This study's enrollment of 15 is below the median of 100 across 309 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

This is the only study on the registry with Karl-Andre Wian as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients in the intensive care unit needing vasopressor for septic shock.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years or older
  • Septic shock patients in ICU department requiring vasopressor therapy

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Septic shock and vasopressor

    Measuring cerebral oxymetry (SCO2) first 24 hours in septic shock and given vasopressors.

06

What researchers measure

Primary outcomes

  1. Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours

    SCO2 will be measured before initiating vasopressor therapy. Thereafter SCO2 are updated every 2 seconds and is measured for 24 hours.

    Time frame: 24 hours

Secondary outcomes

  1. Incidence of acute myocardial infarction

    Incidence of acute myocardial infarction based on international criteria

    Time frame: Hospital discharge, expected 12 days at average

  2. Use of vasopressors/inotropes

    Use of vasopressors/inotropes * norepinephrine * epinephrine * dopamine * dobutamine * vasopressin * nitroprusside * glyceryltrinitrate

    Time frame: Discharge from ICU, expected 5 days at average

  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

    Measuring Sequential Organ Failure Assessment, SOFA, score at inclusion and once daily during ICU-stay.

    Time frame: Discharge from ICU, expected 5 days at average

07

Study locations

1 site
  • Sykehuset i Vestfold HF
    Tønsberg, Vestfold N-3117, Norway
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2015, a primary completion of Jan 2017 and a completion of Jan 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2014
First posted
Sep 11, 2014
Start
Feb 2015
Primary completionActual
Jan 2017
CompletionActual
Jan 2017
Last update
Apr 27, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02237833
Lead sponsor
Karl-Andre Wian
Responsible party
Karl-Andre Wian (MD, Sykehuset i Vestfold HF) — Sponsor-investigator
First posted
Sep 11, 2014
Start date
Feb 2015
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Apr 27, 2017

Study contacts

Karl-Andre Wian, cand.med.
principal investigator · Syekhuset Vestfold HF

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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