Septic Shock and Delirium Because of rSO2 Abnormalities i... | NCT01836302

Studies
Septic Shock and Delirium Because of rSO2 Abnormalities in Intensive Care Unit Patients (The SAD BRAIN Study)

NCT01836302

Sponsor

University of Manitoba

Status

Completed

Last Update Posted

Dec 10, 2013Estimated

Enrollment

16Actual

Phase

Not provided

Conditions

Septic Shock
Delirium
Renal Failure

Interventions

Observation

Countries

Canada

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

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Apr 16, 2013

First Submission Date that Met QC Criteria

Apr 18, 2013

First Posted Date

Apr 19, 2013Estimated

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

Dec 6, 2013

Last Update Posted Date

Dec 10, 2013Estimated

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

Delirium in the ICU is a prevalent problem occurring in up to 80% of ICU patients. A potential cause of delirium in ICU patients could be cerebral hypoxia. Septic shock is associated with high rates of delirium.

The aim of this pilot study is two fold. First, to determine the feasibility and potential challenges of measuring cerebral oxygenation in ICU patients with severe sepsis and septic shock. And second, to see if the incidence and magnitude of cerebral desaturations correlated with ICU acquired delirium as measured by the Confusion Assessment Method (CAM) scores.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Cerebral Desaturation		We will compare the primary and secondary outcomes between the patients who experience cerebral desaturations and those that do not.	Other: Observation
Patients without cerebral desaturation		We will compare the primary and secondary outcomes between the patients who experience cerebral desaturations and those that do not.	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other		Patients with Cerebral Desaturation Patients without cerebral desaturation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Delirium		28 Days

Secondary Outcomes

Measure	Description	Time Frame
Death		28 Days

Other Outcomes

Measure	Description	Time Frame
Renal Failure	Defined using RIFLE Criteria	28 Days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18
Diagnosis of septic shock
Require mechanical ventilation and vasopressor therapy

Exclusion Criteria:

Previous stroke
Dementia
Recent Craniotomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients admitted to the Intensive Care Unit with Septic Shock

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Sciences Center		Winnipeg	Manitoba	R3A1R9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic
D003693	Delirium
D051437	Renal Insufficiency

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided