Cerebrovascular Autoregulation During Sepsis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patrick Schramm, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01029080
First received: December 8, 2009
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention
Sepsis
Delirium
Other: no interventions

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dynamic Cerebrovascular Autoregulation During Sepsis and Sepsis-associated Delirium

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Disturbed cerebrovascular autoregulation correlates with sepsis associated delir [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The Index of autoregulation (Mx) was measured and correlated with the clinical incidence of a sepsis associated delir


Secondary Outcome Measures:
  • Correlation between inflammatory parameters and disturbed cerebrovascular autoregulation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Correlation between inflammatory parameters and sepsis-associated delirium [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sepsis
All patients with sepsis defined by actually sepsis guidelines
Other: no interventions
No interventions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029080

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

Publications:
Responsible Party: Patrick Schramm, Senior Physician, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01029080     History of Changes
Other Study ID Numbers: 837.435.08
Study First Received: December 8, 2009
Last Updated: April 12, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Delirium
Sepsis
Toxemia
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014