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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
Information provided by (Responsible Party):
Patrick Schramm, Johannes Gutenberg University Mainz

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

Condition or disease Intervention/treatment
Sepsis Delirium Other: no interventions

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dynamic Cerebrovascular Autoregulation During Sepsis and Sepsis-associated Delirium
Study Start Date : December 2009
Primary Completion Date : December 2010
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium Sepsis
U.S. FDA Resources

Group/Cohort Intervention/treatment
All patients with sepsis defined by actually sepsis guidelines
Other: no interventions
No interventions

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Correlation between inflammatory parameters and disturbed cerebrovascular autoregulation [ Time Frame: 1 year ]
  2. Correlation between inflammatory parameters and sepsis-associated delirium [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients at intensive care unit were screened to symptoms that definate sepsis

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029080

University medical centre Mainz
Mainz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz

Responsible Party: Patrick Schramm, Senior Physician, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01029080     History of Changes
Other Study ID Numbers: 837.435.08
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013

Keywords provided by Patrick Schramm, Johannes Gutenberg University Mainz:
Brain, blood flow
Measurement techniques, flow velocity waveform analysis
Monitoring, intensive care
transcranial doppler ultrasound (TCD)
Cerebrovascular autoregulation
sepsis-associated delir

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders