NCT01029080

Brief Summary

The aim of the study is to correlate the dynamic cerebrovascular autoregulation by patients with sepsis with a sepsis-associated delirium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2009

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

December 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

December 8, 2009

Last Update Submit

April 12, 2013

Conditions

SepsisDelirium

Keywords

Brain, blood flowMeasurement techniques, flow velocity waveform analysisMonitoring, intensive careSepsistranscranial doppler ultrasound (TCD)Cerebrovascular autoregulationsepsis-associated delir

Outcome Measures

Primary Outcomes (1)

  • Disturbed cerebrovascular autoregulation correlates with sepsis associated delir

    The Index of autoregulation (Mx) was measured and correlated with the clinical incidence of a sepsis associated delir

    1 year

Secondary Outcomes (2)

  • Correlation between inflammatory parameters and disturbed cerebrovascular autoregulation

    1 year

  • Correlation between inflammatory parameters and sepsis-associated delirium

    1 year

Study Arms (1)

Sepsis

All patients with sepsis defined by actually sepsis guidelines

Other: no interventions

Interventions

no interventionsOTHER

No interventions

Sepsis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients at intensive care unit were screened to symptoms that definate sepsis

You may qualify if:

  • clinical symptoms of sepsis, severe sepsis and septic shock
  • possibility for measurement of transcranial doppler ultrasound
  • age over 18 years

You may not qualify if:

  • preexisting cerebrovascular disease
  • preexisting immunological disease
  • traumatic brain injury
  • intracranial infectious disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University medical centre Mainz

Mainz, 55131, Germany

Location

Related Publications (1)

  • Schramm P, Klein KU, Falkenberg L, Berres M, Closhen D, Werhahn KJ, David M, Werner C, Engelhard K. Impaired cerebrovascular autoregulation in patients with severe sepsis and sepsis-associated delirium. Crit Care. 2012 Oct 4;16(5):R181. doi: 10.1186/cc11665.

    PMID: 23036135RESULT

MeSH Terms

Conditions

SepsisDelirium

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations

DE(1)