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CRRT for Glutamate Elimination After Cardiac Arrest (GCRRT)

Primary Purpose

Reperfusion Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Continuous renal replacement therapy
Sponsored by
C. Storm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reperfusion Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • post cardiac arrest

Exclusion Criteria:

  • hemodynamic instable
  • in-hospital cardiac arrest

Sites / Locations

  • Charité-Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CRRT after cardiac arrest

control

Arm Description

Continuous renal replacement therapy (CRRT) after cardiac arrest for 72 hours for elimination of Glutamate. Repetitive testing of blood Glutamate levels.

Repetitive testing of blood Glutamate levels without CRRT

Outcomes

Primary Outcome Measures

Glutamate blood concentration in intervention arm over the time
Reduction of blood Glutamate concentration by renal replacement therapy

Secondary Outcome Measures

number of participants with abnormal outcome parameters

Full Information

First Posted
October 11, 2016
Last Updated
June 20, 2019
Sponsor
C. Storm
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1. Study Identification

Unique Protocol Identification Number
NCT02963298
Brief Title
CRRT for Glutamate Elimination After Cardiac Arrest
Acronym
GCRRT
Official Title
Pilot Trial Concerning Glutamate Elimination With CRRT for Neurological Outcome After Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 6, 2017 (Actual)
Study Completion Date
September 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
C. Storm

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Glutamate is known to be a mediator for apoptosis after brain hypoxia e.g. due to cardiac arrest. This pilot trial evaluates the possibility of elimination of Glutamate by CRRT after cardiac arrest.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reperfusion Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRRT after cardiac arrest
Arm Type
Active Comparator
Arm Description
Continuous renal replacement therapy (CRRT) after cardiac arrest for 72 hours for elimination of Glutamate. Repetitive testing of blood Glutamate levels.
Arm Title
control
Arm Type
No Intervention
Arm Description
Repetitive testing of blood Glutamate levels without CRRT
Intervention Type
Procedure
Intervention Name(s)
Continuous renal replacement therapy
Primary Outcome Measure Information:
Title
Glutamate blood concentration in intervention arm over the time
Description
Reduction of blood Glutamate concentration by renal replacement therapy
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
number of participants with abnormal outcome parameters
Time Frame
up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: post cardiac arrest Exclusion Criteria: hemodynamic instable in-hospital cardiac arrest
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Storm, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité-Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
31557520
Citation
Nee J, Jorres A, Krannich A, Leithner C, Schroeder T, Munk AL, Enghard P, Moore C, Steppan S, Storm C. Elimination of glutamate using CRRT for 72 h in patients with post-cardiac arrest syndrome: A randomized clinical pilot trial. Resuscitation. 2019 Nov;144:54-59. doi: 10.1016/j.resuscitation.2019.09.020. Epub 2019 Sep 23.
Results Reference
derived

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CRRT for Glutamate Elimination After Cardiac Arrest

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