NCT00772096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 sepsis

Timeline
Completed

Started Oct 2008

Typical duration for phase_4 sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

2.7 years

First QC Date

October 14, 2008

Last Update Submit

March 9, 2015

Conditions

SepsisSevere Sepsis

Study Arms (2)

Verum

EXPERIMENTAL
Drug: n-3 fatty acids

No treatment

NO INTERVENTION

Interventions

n-3 fatty acidsDRUG
Verum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 24660837DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Luzius A Steiner, MD, PhD

    Department of Anaesthesia, University Hospital Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2008

First Posted

October 15, 2008

Study Start

October 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

CH(1)