Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination (SepsAR3)
Primary Purpose
Septic Shock
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cytokine absorption
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring Cerebrovascular Autoregulation, Septic Shock, Cytokine
Eligibility Criteria
Inclusion Criteria:
- septic shock
- acute renal failure with need for renal replacement therapy
Exclusion Criteria:
- pregnancy
- nursing
- impossibility to do transcranial Doppler ultrasound
Sites / Locations
- University Medical Center of the Johannes Gutenberg-UniverityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Filter
Control
Arm Description
Patients with CytoSorb absorber
Patients without CytoSorb absorber
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04259567
First Posted
January 31, 2020
Last Updated
June 9, 2020
Sponsor
Johannes Gutenberg University Mainz
1. Study Identification
Unique Protocol Identification Number
NCT04259567
Brief Title
Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination
Acronym
SepsAR3
Official Title
Verbesserung Einer gestörten zerebrovaskulären Autoregulation Bei Patienten im Septischen Schock Durch Extrakorporale Reduktion Von Entzündungsmediatoren
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Cerebrovascular Autoregulation, Septic Shock, Cytokine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Filter
Arm Type
Active Comparator
Arm Description
Patients with CytoSorb absorber
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients without CytoSorb absorber
Intervention Type
Device
Intervention Name(s)
Cytokine absorption
Intervention Description
Use of CytoSorb absorber
Primary Outcome Measure Information:
Title
Differences in the index of cerebrovascular autoregulation (Mx) between both groups
Description
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.
Time Frame
days 1 to 4 after diagnosis of septic shock
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
septic shock
acute renal failure with need for renal replacement therapy
Exclusion Criteria:
pregnancy
nursing
impossibility to do transcranial Doppler ultrasound
Facility Information:
Facility Name
University Medical Center of the Johannes Gutenberg-Univerity
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Schramm, MD
Phone
00496131176755
Email
schrammp@uni-mainz.de
First Name & Middle Initial & Last Name & Degree
Patrick Schramm, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination
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