Pathogenesis and Cerebrovascular Manifestations of Septic... | NCT00410111

Studies
Pathogenesis and Cerebrovascular Manifestations of Septic Encephalopathy

NCT00410111

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Oct 16, 2008Estimated

Enrollment

23Actual

Phase

Not provided

Conditions

Sepsis

Interventions

Not provided

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

Oct 2008

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

Jan 2007

Primary Completion Date

Not provided

Completion Date

Jul 2007Actual

First Submitted Date

Dec 11, 2006

First Submission Date that Met QC Criteria

Dec 11, 2006

First Posted Date

Dec 12, 2006Estimated

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

Oct 15, 2008

Last Update Posted Date

Oct 16, 2008Estimated

Description Module

Brief Summary

Septic encephalopathy is an important complication of sepsis. Why some patients with sepsis develop septic encephalopathy is unknown. We will investigate whether patients who develop this condition have different patterns of cerebrovascular reactivity and whether it is possible to predict the development of septic encephalopathy from early measurements of cerebral perfusion or from the EEG. We will specifically test the hypotheses that septic encephalopathy may not be predicted by changes in the EEG, and that cerebrovascular autoregulation is not dysfunctional in septic encephalopathy.

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

Not provided

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

23Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sepsis
Admission to ICU

Exclusion Criteria:

CNS infection
History of cerebrovascular disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with sepsis, severe sepsis or septic shock admitted to an intensive care unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Operative Intensivbehandlung, University of Basel Hospital		Basel		4031	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18457586	Derived	Pfister D, Siegemund M, Dell-Kuster S, Smielewski P, Ruegg S, Strebel SP, Marsch SC, Pargger H, Steiner LA. Cerebral perfusion in sepsis-associated delirium. Crit Care. 2008;12(3):R63. doi: 10.1186/cc6891. Epub 2008 May 5.

ID	Term
D018805	Sepsis
D001927	Brain Diseases

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