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Cerebrovascular Autoregulation in Sepsis, Influence of Renal Replacement Therapy (SepsAR2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01926301
Recruitment Status : Withdrawn
First Posted : August 20, 2013
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Patrick Schramm, Johannes Gutenberg University Mainz

Brief Summary:

The cerebrovascular autoregulation is impaired in patients with severe sepsis and septic shock. A continuous veno-venous hemodialysis may improve impaired cerebrovascular autoregulation.

Hypothesis: continuous hemodialysis recovers impaired cerebrovascular autoregulation in patients with acute severe sepsis and septic shock.


Condition or disease Intervention/treatment
Severe Sepsis Septic Shock Procedure: continuous veno-venous hemodialysis

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cerebrovascular Autoregulation in Patients With Severe Sepsis and Septic Shock, Influence of Renal Replacement Therapy
Study Start Date : August 2013
Actual Primary Completion Date : June 2020
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hemodialysis
Patients with severe sepsis or septic shock with acute renal failure and requirement of continuous veno-venous hemodialysis
Procedure: continuous veno-venous hemodialysis
Other Name: Renal replacement therapy

No hemodialysis
Patients with severe sepsis or septic shock without acute renal failure and no requirement of continuous veno-venous hemodialysis



Primary Outcome Measures :
  1. Cerebrovascular autoregulation [ Time Frame: during the first 4 days ]
    Cerebrovascular autoregulation measured daily at the first 4 days of severe sepsis and septic shock


Secondary Outcome Measures :
  1. Delirium [ Time Frame: at day 4 ]
    Incidence of Delirium at day 4 after severe sepsis or septic shock


Biospecimen Retention:   Samples Without DNA
Serum and whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with severe sepsis or septic shock at the intensive care unit of an university general hospital
Criteria

Inclusion Criteria:

  • severe sepsis or septic shock
  • adult patients
  • possibility of transcranial Doppler ultrasound

Exclusion Criteria:

  • traumatic brain injury
  • known cerebrovascular diseases
  • Infection of the brain
  • chronic renal failure
  • 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): NCT01926301


Locations
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Germany
University Medical Center of the Johannes Gutenberg-Univerity
Mainz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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Principal Investigator: Patrick Schramm, MD University Medical Center of the Johannes Gutenberg University Mainz, Germany
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Responsible Party: Patrick Schramm, Associate Professor, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01926301    
Other Study ID Numbers: 83743712
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Keywords provided by Patrick Schramm, Johannes Gutenberg University Mainz:
sepsis
cerebrovascular autoregulation
delirium
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock