Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

CRRT for Glutamate Elimination After Cardiac Arrest (GCRRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02963298
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
C. Storm, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE October 11, 2016
First Posted Date  ICMJE November 15, 2016
Last Update Posted Date June 21, 2019
Study Start Date  ICMJE October 2016
Actual Primary Completion Date September 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
Glutamate blood concentration in intervention arm over the time [ Time Frame: 72 hours ]
Reduction of blood Glutamate concentration by renal replacement therapy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
number of participants with abnormal outcome parameters [ Time Frame: up to 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CRRT for Glutamate Elimination After Cardiac Arrest
Official Title  ICMJE Pilot Trial Concerning Glutamate Elimination With CRRT for Neurological Outcome After Cardiac Arrest
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Reperfusion Syndrome
Intervention  ICMJE Procedure: Continuous renal replacement therapy
Study Arms  ICMJE
  • Active Comparator: CRRT after cardiac arrest
    Continuous renal replacement therapy (CRRT) after cardiac arrest for 72 hours for elimination of Glutamate. Repetitive testing of blood Glutamate levels.
    Intervention: Procedure: Continuous renal replacement therapy
  • No Intervention: control
    Repetitive testing of blood Glutamate levels without CRRT
Publications * Nee J, Jörres 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2018)
42
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2016)
40
Actual Study Completion Date  ICMJE September 6, 2017
Actual Primary Completion Date September 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • post cardiac arrest

Exclusion Criteria:

  • hemodynamic instable
  • in-hospital cardiac arrest
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02963298
Other Study ID Numbers  ICMJE Glu2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party C. Storm, Charite University, Berlin, Germany
Study Sponsor  ICMJE C. Storm
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian Storm, MD Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP