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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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date August 17, 2013
First Posted Date August 20, 2013
Last Update Posted Date June 11, 2020
Study Start Date August 2013
Actual Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2013)
Cerebrovascular autoregulation [ Time Frame: during the first 4 days ]
Cerebrovascular autoregulation measured daily at the first 4 days of severe sepsis and septic shock
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 17, 2013)
Delirium [ Time Frame: at day 4 ]
Incidence of Delirium at day 4 after severe sepsis or septic shock
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 in Sepsis, Influence of Renal Replacement Therapy
Official Title Cerebrovascular Autoregulation in Patients With Severe Sepsis and Septic Shock, Influence of Renal Replacement Therapy
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum and whole blood
Sampling Method Probability Sample
Study Population Patients with severe sepsis or septic shock at the intensive care unit of an university general hospital
Condition
  • Severe Sepsis
  • Septic Shock
Intervention Procedure: continuous veno-venous hemodialysis
Other Name: Renal replacement therapy
Study Groups/Cohorts
  • Hemodialysis
    Patients with severe sepsis or septic shock with acute renal failure and requirement of continuous veno-venous hemodialysis
    Intervention: Procedure: continuous veno-venous hemodialysis
  • No hemodialysis
    Patients with severe sepsis or septic shock without acute renal failure and no requirement of continuous veno-venous hemodialysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: June 9, 2020)
0
Original Estimated Enrollment
 (submitted: August 17, 2013)
47
Actual Study Completion Date June 2020
Actual Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility 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
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 NCT01926301
Other Study ID Numbers 83743712
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
Principal Investigator: Patrick Schramm, MD University Medical Center of the Johannes Gutenberg University Mainz, Germany
PRS Account Johannes Gutenberg University Mainz
Verification Date June 2020