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Cerebrovascular Autoregulation During Sepsis

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ClinicalTrials.gov Identifier: NCT01029080
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : April 15, 2013
Sponsor:
Information provided by (Responsible Party):
Patrick Schramm, Johannes Gutenberg University Mainz

Tracking Information
First Submitted Date December 8, 2009
First Posted Date December 9, 2009
Last Update Posted Date April 15, 2013
Study Start Date December 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2011)
Disturbed cerebrovascular autoregulation correlates with sepsis associated delir [ Time Frame: 1 year ]
The Index of autoregulation (Mx) was measured and correlated with the clinical incidence of a sepsis associated delir
Original Primary Outcome Measures
 (submitted: December 8, 2009)
Is there a correlation between disturbed cerebrovascular autoregulation during sepsis with the incidence of sepsis-associated delirium [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT01029080 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 8, 2009)
  • Correlation between inflammatory parameters and disturbed cerebrovascular autoregulation [ Time Frame: 1 year ]
  • Correlation between inflammatory parameters and sepsis-associated delirium [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cerebrovascular Autoregulation During Sepsis
Official Title Dynamic Cerebrovascular Autoregulation During Sepsis and Sepsis-associated Delirium
Brief Summary The aim of the study is to correlate the dynamic cerebrovascular autoregulation by patients with sepsis with a sepsis-associated delirium.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All patients at intensive care unit were screened to symptoms that definate sepsis
Condition
  • Sepsis
  • Delirium
Intervention Other: no interventions
No interventions
Study Groups/Cohorts Sepsis
All patients with sepsis defined by actually sepsis guidelines
Intervention: Other: no interventions
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 8, 2009)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • preexisting cerebrovascular disease
  • preexisting immunological disease
  • traumatic brain injury
  • intracranial infectious disease
  • pregnancy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01029080
Other Study ID Numbers 837.435.08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Patrick Schramm, Johannes Gutenberg University Mainz
Study Sponsor Johannes Gutenberg University Mainz
Collaborators Not Provided
Investigators Not Provided
PRS Account Johannes Gutenberg University Mainz
Verification Date April 2013