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NCT04259567 Clinical Trial

Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination

Septic Shock Clinical Trial

— SepsAR3  

Official title:
Verbesserung Einer gestörten zerebrovaskulären Autoregulation Bei Patienten im Septischen Schock Durch Extrakorporale Reduktion Von Entzündungsmediatoren

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04259567
Other study ID # V1.0_2019_06_28
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 8, 2020
Est. completion date July 31, 2022

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

Clinical Trial Summary

The trial investigates the effect of cytokine elimination in patients with septic schock and acute renal failure with need for renal replacement therapy on the integrity of cerebrovascular autoregulation. Patients with inclusion criteria were randomly assign in either use of CytoSorb filter integrated in renal replacement therapy versus non additional filter an renal replacement therapy alone. Cerebrovascular autoregulation will be measured with transcranial Doppler ultrasound and correlation with arterial blood pressure.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date July 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- septic shock

- acute renal failure with need for renal replacement therapy

Exclusion Criteria:

- pregnancy

- nursing

- impossibility to do transcranial Doppler ultrasound

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cytokine absorption
Use of CytoSorb absorber

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 Differences in the index of cerebrovascular autoregulation (Mx) between both groups Integrity of the cerebrovascular autoregulation will be measured using the index of cerebrovascular autoregulation Mx (moving correlation index). Outcome is the difference of the mean Mx between both groups and, therefore, the difference of integrity of the cerbrovascular autoregulation. A difference of 0.2 in Mx was set as clinically relevant. days 1 to 4 after diagnosis of septic shock
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