Reperfusion SyndromeGCRRTNCT02963298
CRRT for Glutamate Elimination After Cardiac Arrest
A study testing Continuous renal replacement therapy in people with Reperfusion Syndrome, run by C. Storm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reperfusion Syndrome
- What is being tested?
- Continuous renal replacement therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2016to 6 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post cardiac arrest
Who cannot join
- hemodynamic instable
- in-hospital cardiac arrest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial Concerning Glutamate Elimination With CRRT for Neurological Outcome After Cardiac Arrest
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.
- Conditions
- Reperfusion Syndrome
- Being tested
- Continuous renal replacement therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous renal replacement therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Continuous renal replacement therapy |
| control | No intervention | Repetitive testing of blood Glutamate levels without CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutamate blood concentration in intervention arm over the time
Reduction of blood Glutamate concentration by renal replacement therapy
Measured: 72 hours
Secondary outcomes (1)
number of participants with abnormal outcome parameters
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startOct 2016
- Primary completion6 Sep 2017
- Study completion6 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reperfusion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. Storm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, C. Storm, Charite University, Berlin, Germany
- Investigators
- Christian Storm, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963298
- Sponsor's protocol ID
- Glu2016
- Acronym
- GCRRT
- Status last verified
- Jun 2019
- First submitted
- 11 Oct 2016
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31557520
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial Concerning Glutamate Elimination With CRRT for Neurological Outcome After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02963298
- Acronym / sponsor ID
- GCRRT / Glu2016
- Conditions
- Reperfusion Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- C. StormUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRRT after cardiac arrest | Active comparator | Procedure: Continuous renal replacement therapyContinuous renal replacement therapy (CRRT) after cardiac arrest for 72 hours for elimination of Glutamate. Repetitive testing of blood Glutamate levels. |
| control | No intervention | –Repetitive testing of blood Glutamate levels without CRRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- post cardiac arrest
Key exclusion criteria (2 listed)
- hemodynamic instable
- in-hospital cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous renal replacement therapy | Procedure or surgery | CRRT after cardiac arrest |
Primary outcome
Glutamate blood concentration in intervention arm over the time
Time frame: 72 hours
Reduction of blood Glutamate concentration by renal replacement therapy
1 secondary outcome
number of participants with abnormal outcome parameters
Time frame: up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Derived from this study: PubMed 31557520Nee 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.
Related trials for Reperfusion Syndrome
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Not yet recruiting
Remote Ischemic Postconditioning in Septic Shock
Adult Patients With Septic Shock Admitted in Intensive Care Unit
Recruiting
Cerebral Oximetry in Management of Post Cardiac Arrest
Post-Cardiac Arrest Syndrome, Post Cardiac Arrest Brain Injury
RecruitingObservational study
The Holistic Health Care of Post-Cardiac Arrest Survivors: From Patient's Health to Family Resilience
Post-Cardiac Arrest Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Storm, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous renal replacement therapy in people with Reperfusion Syndrome, run by C. Storm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glutamate blood concentration in intervention arm over the time (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02963298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.