Septic Encephalopathy and Late Cognitive Dysfunction | NCT00772096

Studies
Septic Encephalopathy and Late Cognitive Dysfunction

NCT00772096

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Mar 10, 2015Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Sepsis
Severe Sepsis

Interventions

n-3 fatty acids

Countries

Switzerland

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

Mar 2015

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

Oct 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Oct 14, 2008

First Submission Date that Met QC Criteria

Oct 14, 2008

First Posted Date

Oct 15, 2008Estimated

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

Mar 9, 2015

Last Update Posted Date

Mar 10, 2015Estimated

Description Module

Brief Summary

Delirium and long-term cognitive dysfunction are important problems in intensive care patients. Patients with sepsis are at a high risk of developing delirium (septic encephalopathy), which may be an important risk factor for the development of long-term cognitive dysfunction.

Working hypotheses: 1. Septic encephalopathy and cognitive dysfunction are caused by an unspecific reaction of the brain to an intense inflammatory stimulus. 2. It is possible to therapeutically influence the inflammatory response and its effects on the brain.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
Verum	Experimental		Drug: n-3 fatty acids
No treatment	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
n-3 fatty acids	Drug		Verum

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted to an intensive care unit for treatment of sepsis, severe sepsis or septic shock
Age 18 or older

Exclusion Criteria:

Primary infection of the CNS
History of cerebrovascular disease
History of any neoplasia involving the CNS
History of long-term psychiatric medication
History of allergy to fish- or egg-protein
Severe coagulation abnormalities
Clinical signs of altered coagulation, active bleeding
Pregnancy

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luzius A Steiner, MD, PhD	Department of Anaesthesia, University Hospital Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel	Basel	4031	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24660837	Derived	Burkhart CS, Dell-Kuster S, Siegemund M, Pargger H, Marsch S, Strebel SP, Steiner LA. Effect of n-3 fatty acids on markers of brain injury and incidence of sepsis-associated delirium in septic patients. Acta Anaesthesiol Scand. 2014 Jul;58(6):689-700. doi: 10.1111/aas.12313. Epub 2014 Mar 24.

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids