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NCT01926301 Clinical Trial

Cerebrovascular Autoregulation in Sepsis, Influence of Renal Replacement Therapy

Septic Shock Clinical Trial

— SepsAR2  

Official title:
Cerebrovascular Autoregulation in Patients With Severe Sepsis and Septic Shock, Influence of Renal Replacement Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01926301
Other study ID # 83743712
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date August 2013
Est. completion date June 2020

Study information
Verified date June 2020
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• continuous veno-venous hemodialysis

Locations
Country Name City State
Germany University Medical Center of the Johannes Gutenberg-Univerity Mainz

Sponsors (1)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cerebrovascular autoregulation Cerebrovascular autoregulation measured daily at the first 4 days of severe sepsis and septic shock during the first 4 days
Secondary Delirium Incidence of Delirium at day 4 after severe sepsis or septic shock at day 4
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