Cerebral Oxygenation in Septic Patients Using Vasopressor... | NCT02237833

Studies
Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study

NCT02237833

Sponsor

Karl-Andre Wian

Status

Terminated

Last Update Posted

Apr 27, 2017Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Septic Shock

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Too slow recruitment.

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Sep 8, 2014

First Submission Date that Met QC Criteria

Sep 9, 2014

First Posted Date

Sep 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2017

Last Update Posted Date

Apr 27, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Septic shock and vasopressor		Measuring cerebral oxymetry (SCO2) first 24 hours in septic shock and given vasopressors.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Incidence of acute myocardial infarction	Incidence of acute myocardial infarction based on international criteria	Hospital discharge, expected 12 days at average
Use of vasopressors/inotropes

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karl-Andre Wian, cand.med.	Syekhuset Vestfold HF	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sykehuset i Vestfold HF		Tønsberg	Vestfold	N-3117	Norway

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

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Browse Branches

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