Cardiac ArrestPhase 2NCT00797680
Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest
A Phase 2 study testing 72 hours hypothermia and 24 hours hypothermia in people with Cardiac Arrest and Brain Injury, run by University of Pittsburgh at 1 site in United States.
Trial summary
In this study, children who survive cardiac arrest will be evaluated whether 24 or 72 hours of whole body hypothermia (cooling) during recovery is better to help prevent brain injury and improve outcome. The investigators will also test the safety of cooling patients for 24 and 72 hours. Read more about this study
- Who is it for?
- Ages 1 week to 17 years
- Conditions the study is for
- Cardiac Arrest, Brain Injury
- What is being tested?
- 72 hours hypothermia and 24 hours hypothermia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Apr 2015
- Phase
- Phase 2
- 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 1 week to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Chest compressions by a health care worker Age 1 wk - 17 yr ROSC attained PICU attending decides to cool Central venous or arterial catheter Glasgow Coma Score ≤ 8
Who cannot join
- Other acute brain injury (TBI, meningitis) Do not resuscitate status Pregnancy Absolute contraindication to MRI Brain death evaluation Metabolic disorder Active hemorrhage Pre-existing coagulation defect
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
In this study, children who survive cardiac arrest will be evaluated whether 24 or 72 hours of whole body hypothermia (cooling) during recovery is better to help prevent brain injury and improve outcome. The investigators will also test the safety of cooling patients for 24 and 72 hours. The investigators hypothesize that 72 hours of cooling will be more beneficial than 24 hours without compromising safety.
Read the detailed description
Cooling has been shown to decrease the amount of brain injury that can occur after heart attacks in adults and in newborn babies with birth asphyxia (a lack of blood flow and oxygen to the fetus). It is unknown if cooling is effective in children after cardiac arrest. However, cooling is recommended by the American Heart Association as a "consideration" for use in children after cardiac arrest to prevent brain injury and has been used by doctors in our intensive care unit since 2002.
Children will be randomly assigned to receive either 24 or 72 hours of cooling and compare the results of 1) blood-and urine derived markers of brain injury, and 2) brain magnetic resonance imaging and spectroscopy (MRI and MRS), which measures the anatomy and chemical patterns in the brain without using ionizing radiation, between the two groups of patients with 24 or 72 hours of cooling. We will also evaluate if cooling has any effect on patient outcome and quality of life at 6 months and one year using telephone or mail questionnaires.
A child may take part in this research study if he or she had a cardiac arrest, received help with breathing and chest compressions to get a spontaneous heart rate by a health care worker, and remains unconscious in the intensive care unit (ICU). The attending physician in the ICU has already decided to cool your child to provide protection for his or her brain function.
Children invited to participate in this study also are between 1 week and 17 years of age, have access tubes already in place in an artery or vein for blood draws, a urine catheter, are able to undergo MRI and MRS brain scans, and, if female, cannot be pregnant.
Patients can not have had an acute brain injury from other causes (ex., meningitis, trauma), hemorrhage (excess bleeding from any site), congenital heart disease, do not resuscitate status, are undergoing a brain death examination, or have a known coagulation defect that makes them bleed more easily. The study will be performed on a total of 40 children strictly in this hospital.
- Conditions
- Cardiac Arrest, Brain Injury
- Being tested
- 72 hours hypothermia, 24 hours hypothermia
- Keywords
- Pediatric cardiac arrest
- Medical subject headings
- Heart Arrest, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
72 hours hypothermiaOther
72 hours mild hypothermia (33 +/1 1 degree Celsius)
24 hours hypothermiaOther
24 hours mild hypothermia (33 +/1 1 degree Celsius)
| Study group | Role | What they receive |
|---|---|---|
| 72 hours hypothermia | Experimental | 72 hours hypothermia Receives: Other: 72 hours hypothermia |
| 24 hours hypothermia | Experimental | 24 hours hypothermia Receives: Other: 24 hours hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of brain injury as measured by serum and urine biomarkers and Magnetic Resonance Spectroscopy
Measured: hospital discharge
Secondary outcomes (1)
Frequency of adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Laerdal Medical
- Responsible party
- Principal investigator, Ericka Fink, University of Pittsburgh
- Investigators
- Ericka L Fink, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797680
- Sponsor's protocol ID
- ef1
- Other IDs
- K23NS065132
- Status last verified
- Jan 2016
- First submitted
- 24 Nov 2008
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kernan KF, Berger RP, Clark RSB, Scott Watson R, Angus DC, Panigrahy A, Callaway CW, Bell MJ, Kochanek PM, Fink EL, Simon DW. An exploratory assessment of serum biomarkers of post-cardiac arrest syndrome in children. Resuscitation. 2021 Oct;167:307-316. doi: 10.1016/j.resuscitation.2021.07.007. Epub 2021 Jul 14.
PubMed 34271122Fink EL, Wisnowski J, Clark R, Berger RP, Fabio A, Furtado A, Narayan S, Angus DC, Watson RS, Wang C, Callaway CW, Bell MJ, Kochanek PM, Bluml S, Panigrahy A. Brain MR imaging and spectroscopy for outcome prognostication after pediatric cardiac arrest. Resuscitation. 2020 Dec;157:185-194. doi: 10.1016/j.resuscitation.2020.06.033. Epub 2020 Jul 9.
PubMed 32653571
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00797680
- Acronym / sponsor ID
- ef1
- Conditions
- Cardiac Arrest, Brain Injury
- Keywords
- Pediatric cardiac arrest
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Laerdal Medical
- Study start
- Oct 2008
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Nov 2008 (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.
In this study, children who survive cardiac arrest will be evaluated whether 24 or 72 hours of whole body hypothermia (cooling) during recovery is better to help prevent brain injury and improve outcome. The investigators will also test the safety of cooling patients for 24 and 72 hours. The investigators hypothesize that 72 hours of cooling will be more beneficial than 24 hours without compromising safety.
Detailed description
Cooling has been shown to decrease the amount of brain injury that can occur after heart attacks in adults and in newborn babies with birth asphyxia (a lack of blood flow and oxygen to the fetus). It is unknown if cooling is effective in children after cardiac arrest. However, cooling is recommended by the American Heart Association as a "consideration" for use in children after cardiac arrest to prevent brain injury and has been used by doctors in our intensive care unit since 2002.
Children will be randomly assigned to receive either 24 or 72 hours of cooling and compare the results of 1) blood-and urine derived markers of brain injury, and 2) brain magnetic resonance imaging and spectroscopy (MRI and MRS), which measures the anatomy and chemical patterns in the brain without using ionizing radiation, between the two groups of patients with 24 or 72 hours of cooling. We will also evaluate if cooling has any effect on patient outcome and quality of life at 6 months and one year using telephone or mail questionnaires.
A child may take part in this research study if he or she had a cardiac arrest, received help with breathing and chest compressions to get a spontaneous heart rate by a health care worker, and remains unconscious in the intensive care unit (ICU). The attending physician in the ICU has already decided to cool your child to provide protection for his or her brain function.
Children invited to participate in this study also are between 1 week and 17 years of age, have access tubes already in place in an artery or vein for blood draws, a urine catheter, are able to undergo MRI and MRS brain scans, and, if female, cannot be pregnant.
Patients can not have had an acute brain injury from other causes (ex., meningitis, trauma), hemorrhage (excess bleeding from any site), congenital heart disease, do not resuscitate status, are undergoing a brain death examination, or have a known coagulation defect that makes them bleed more easily. The study will be performed on a total of 40 children strictly in this hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 72 hours hypothermia | Experimental | Other: 72 hours hypothermia72 hours hypothermia |
| 24 hours hypothermia | Experimental | Other: 24 hours hypothermia24 hours hypothermia |
Who may qualify
- Ages
- 1 week to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Chest compressions by a health care worker Age 1 wk - 17 yr ROSC attained PICU attending decides to cool Central venous or arterial catheter Glasgow Coma Score ≤ 8
Key exclusion criteria (1 listed)
- Other acute brain injury (TBI, meningitis) Do not resuscitate status Pregnancy Absolute contraindication to MRI Brain death evaluation Metabolic disorder Active hemorrhage Pre-existing coagulation defect
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 |
|---|---|---|
| 72 hours hypothermia72 hours mild hypothermia (33 +/1 1 degree Celsius) | Other | 72 hours hypothermia |
| 24 hours hypothermia24 hours mild hypothermia (33 +/1 1 degree Celsius) | Other | 24 hours hypothermia |
Primary outcome
Degree of brain injury as measured by serum and urine biomarkers and Magnetic Resonance Spectroscopy
Time frame: hospital discharge
1 secondary outcome
Frequency of adverse events
Time frame: 30 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 18 Jan 2016.
- Derived from this study: PubMed 34271122Kernan KF, Berger RP, Clark RSB, Scott Watson R, Angus DC, Panigrahy A, Callaway CW, Bell MJ, Kochanek PM, Fink EL, Simon DW. An exploratory assessment of serum biomarkers of post-cardiac arrest syndrome in children. Resuscitation. 2021 Oct;167:307-316. doi: 10.1016/j.resuscitation.2021.07.007. Epub 2021 Jul 14.
- Derived from this study: PubMed 32653571Fink EL, Wisnowski J, Clark R, Berger RP, Fabio A, Furtado A, Narayan S, Angus DC, Watson RS, Wang C, Callaway CW, Bell MJ, Kochanek PM, Bluml S, Panigrahy A. Brain MR imaging and spectroscopy for outcome prognostication after pediatric cardiac arrest. Resuscitation. 2020 Dec;157:185-194. doi: 10.1016/j.resuscitation.2020.06.033. Epub 2020 Jul 9.
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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.
Ericka L Fink, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 72 hours hypothermia and 24 hours hypothermia in people with Cardiac Arrest and Brain Injury, run by University of Pittsburgh at 1 site in United States.
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 1 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 18 Jan 2016. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Degree of brain injury as measured by serum and urine biomarkers and Magnetic Resonance Spectroscopy (time frame: hospital discharge). 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 NCT00797680, which also lists 2 linked publications.
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 18 Jan 2016.