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Septic Encephalopathy and Late Cognitive Dysfunction

Primary Purpose

Sepsis, Severe Sepsis

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

n-3 fatty acids

About this trial

This is an interventional prevention trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Verum

No treatment

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00772096

First Posted

October 14, 2008

Last Updated

March 9, 2015

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT00772096

Brief Title

Septic Encephalopathy and Late Cognitive Dysfunction

Official Title

Septic Encephalopathy and Late Cognitive Dysfunction in Patients With Sepsis - the Role of Inflammation

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis, Severe Sepsis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Verum

Arm Type

Experimental

Arm Title

No treatment

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

n-3 fatty acids

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luzius A Steiner, MD, PhD

Organizational Affiliation

Department of Anaesthesia, University Hospital Basel, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Basel

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

24660837

Citation

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.

Results Reference

derived

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Septic Encephalopathy and Late Cognitive Dysfunction

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