NCT02963298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2017

Completed
Last Updated

June 21, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

October 11, 2016

Last Update Submit

June 20, 2019

Conditions

Reperfusion Syndrome

Outcome Measures

Primary Outcomes (1)

  • Glutamate blood concentration in intervention arm over the time

    Reduction of blood Glutamate concentration by renal replacement therapy

    72 hours

Secondary Outcomes (1)

  • number of participants with abnormal outcome parameters

    up to 14 days

Study Arms (2)

CRRT after cardiac arrest

ACTIVE COMPARATOR

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

Procedure: Continuous renal replacement therapy

control

NO INTERVENTION

Repetitive testing of blood Glutamate levels without CRRT

Interventions

Continuous renal replacement therapyPROCEDURE
CRRT after cardiac arrest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post cardiac arrest

You may not qualify if:

  • hemodynamic instable
  • in-hospital cardiac arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité-Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Related Publications (1)

  • 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.

    PMID: 31557520DERIVED

MeSH Terms

Interventions

Continuous Renal Replacement Therapy

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Christian Storm, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

October 11, 2016

First Posted

November 15, 2016

Study Start

October 1, 2016

Primary Completion

September 6, 2017

Study Completion

September 6, 2017

Last Updated

June 21, 2019

Record last verified: 2019-06

Locations

DE(1)