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Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination (SepsAR3)

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ClinicalTrials.gov Identifier: NCT04259567
Recruitment Status : Unknown
Verified June 2020 by Patrick Schramm, Johannes Gutenberg University Mainz.
Recruitment status was:  Recruiting
First Posted : February 6, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Patrick Schramm, Johannes Gutenberg University Mainz

Study Description
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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.

Condition or disease Intervention/treatment Phase
Septic Shock Device: Cytokine absorption Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Verbesserung Einer gestörten zerebrovaskulären Autoregulation Bei Patienten im Septischen Schock Durch Extrakorporale Reduktion Von Entzündungsmediatoren
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Filter
Patients with CytoSorb absorber
 Device: Cytokine absorption
Use of CytoSorb absorber
No Intervention: Control
Patients without CytoSorb absorber


Outcome Measures
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Primary Outcome Measures :
  1. Differences in the index of cerebrovascular autoregulation (Mx) between both groups [ Time Frame: days 1 to 4 after diagnosis of septic shock ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • septic shock
  • acute renal failure with need for renal replacement therapy

Exclusion Criteria:

  • pregnancy
  • nursing
  • impossibility to do transcranial Doppler ultrasound
Contacts and Locations
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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): NCT04259567


Locations
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Germany
University Medical Center of the Johannes Gutenberg-Univerity Recruiting
Mainz, Germany, 55131
Contact: Patrick Schramm, MD    00496131176755    schrammp@uni-mainz.de   
Principal Investigator: Patrick Schramm, MD         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
More Information
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Responsible Party: Patrick Schramm, Deputy intensive care unit, Principal investigator, medical doctor, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT04259567    
Other Study ID Numbers: V1.0_2019_06_28
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patrick Schramm, Johannes Gutenberg University Mainz:
Cerebrovascular Autoregulation
Septic Shock
Cytokine
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
 Infections
Systemic Inflammatory Response Syndrome
Inflammation