Septic ShockCONSCIOUSNCT02237833
Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study
An observational study of Septic Shock, run by Karl-Andre Wian at 1 site in Norway.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the intensive care unit needing vasopressor for septic shock.
Who may be able to join
- 18 years or older
- Septic shock patients in ICU department requiring vasopressor therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Oxygenation in Septic Patients Using Vasopressors - The Conscious Study
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.
- Conditions
- Septic Shock
- Keywords
- septic shock, cerebral oximetry, vasopressor, norepinephrine
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Septic shock and vasopressor | Measuring cerebral oxymetry (SCO2) first 24 hours in septic shock and given vasopressors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (6)
Incidence of acute myocardial infarction
Incidence of acute myocardial infarction based on international criteria
Measured: Hospital discharge, expected 12 days at average
Use of vasopressors/inotropes
Use of vasopressors/inotropes
- norepinephrine
- epinephrine
- dopamine
- dobutamine
- vasopressin
- nitroprusside
- glyceryltrinitrate
Measured: Discharge from ICU, expected 5 days at average
Fluid balance
Measured: 24 hours
Length of stay in ICU
Measured: Discharge from ICU, expected 5 days at average
Length of stay in hospital
Measured: Discharge from hospital, expected 10 days at average
Incidence of organ failure
Measuring Sequential Organ Failure Assessment, SOFA, score at inclusion and once daily during ICU-stay.
Measured: Discharge from ICU, expected 5 days at average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startFeb 2015
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Too slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karl-Andre Wian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karl-Andre Wian, Sykehuset i Vestfold HF
- Investigators
- Karl-Andre Wian, cand.med., Principal investigator, Syekhuset Vestfold HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237833
- Sponsor's protocol ID
- 2014/194 REK
- Acronym
- CONSCIOUS
- Status last verified
- Apr 2017
- First submitted
- 8 Sep 2014
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation in Septic Patients Using Vasopressors - The Conscious Study
- ClinicalTrials.gov ID
- NCT02237833
- Acronym / sponsor ID
- CONSCIOUS / 2014/194 REK
- Conditions
- Septic Shock
- Keywords
- septic shock, cerebral oximetry, vasopressor, norepinephrine
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Too slow recruitment.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Karl-Andre WianUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic shock and vasopressor | – | –Measuring cerebral oxymetry (SCO2) first 24 hours in septic shock and given vasopressors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the intensive care unit needing vasopressor for septic shock.
Key inclusion criteria (2 listed)
- 18 years or older
- Septic shock patients in ICU department requiring vasopressor therapy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Incidence of acute myocardial infarction
Time frame: Hospital discharge, expected 12 days at average
Use of vasopressors/inotropes
Time frame: Discharge from ICU, expected 5 days at average
Fluid balance
Time frame: 24 hours
Length of stay in ICU
Time frame: Discharge from ICU, expected 5 days at average
Length of stay in hospital
Time frame: Discharge from hospital, expected 10 days at average
Incidence of organ failure
Time frame: Discharge from ICU, expected 5 days at average
Results and safety
The study was stopped early (reason given: Too slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl-Andre Wian, cand.med. principal investigator
Syekhuset Vestfold HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Karl-Andre Wian at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Too slow recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.