Cardiac ArrestPhase 3NSE-HYPERIONNCT02722473
NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.
A Phase 3 study testing NSE dosage "hypothermia arm" and NSE dosage "normothermia arm" in people with Cardiac Arrest and Hypothermia, run by Centre Hospitalier Departemental Vendee at 14 sites in France.
Trial summary
Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Hypothermia, Critical Care
- What is being tested?
- NSE dosage "hypothermia arm" and NSE dosage "normothermia arm"
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 14 sitesFrance
- Study dates
- Mar 2016to 9 Aug 2018
- Phase
- Phase 3
- 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
- Cardiac arrest in nonshockable rhythm and
- Glasgow Coma Scale score ≤8. In patients receiving sedative therapy at ICU admission, the Glasgow Coma Scale score assessed by the emergency physician just before sedative therapy initiation is used.
- Patient must be randomized in a center which participate in the ancillary study.
Who cannot join
- No-flow time >10 min (time from collapse to initiation of external cardiac massage);
- Low-flow time >60 min (time from initiation of external cardiac massage to return of spontaneous circulation).
- Major hemodynamic instability (defined as a continuous epinephrine or norepinephrine infusion at a flow rate >1 μg/Kg/min)
- Time from cardiac arrest to study inclusion >300 min
- Moribund patient
- Child C cirrhosis of the liver
Show all 12Show fewer
- Age <18 years
- Pregnant or breastfeeding woman
- Correctional facility inmate
- Previous inclusion in another randomized clinical trial on cardiac arrest with day-90 neurological outcome as the primary endpoint
- Patient without health insurance
- Decision by the patient or next of kin to refuse the study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Medical Surgical Intensive Care Unit
Annecy
Medical Intensive Care Unit
Clermont-Ferrand
Medical Intensive Care Unit
Dijon
Medical Surgical Intensive Care Unit
La Roche-sur-Yon
Medical Surgical Intensive Care Unit
Lens
Medical Surgical Intensive Care Unit
Limoges
Medical Surgical Intensive Care Unit
Montauban
Medical Intensive Care Unit
Nantes
Medical Surgical Intensive Care Unit
Orléans
Medical Intensive Care Unit
Poitiers
Medical Surgical Intensive Care Unit
Rodez
Medical Surgical Intensive Care Unit
Saint-Brieuc
Medical Surgical Intensive Care Unit
St-Malo
Medical Intensive Care Unit
Tours
About this study
Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.
There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.
NSE-Ancillary Study of HYPERION Trial will determine impact on neurospecific enolase (brain biomarker) of two temperature target for targeted temperature management (33°C or 37°C) after cardiac arrest in non-shockable rhythm.
- Conditions
- Cardiac Arrest, Hypothermia, Critical Care
- Being tested
- NSE dosage "hypothermia arm", NSE dosage "normothermia arm"
- Medical subject headings
- Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSE dosage "hypothermia arm"Biological
There 3 dosage of NSE per patient included: day 1, day 2 and day 3 during targeted temperature management between 33° and 37°C.
NSE dosage "normothermia arm"Biological
There 3 dosage of NSE per patient included: day 1, day 2 and day 3 during targeted temperature management at 37°C.
| Study group | Role | What they receive |
|---|---|---|
| Targeted controlled temperature between 32.5 and 33.5°C | Active comparator | Patients will be placed in targeted temperature control between 32.5 and 33.5°C for 24 hours and then slowly rewarmed for targeted temperature control between 36.5 and 37.5°C for 24 hours. Receives: Biological: NSE dosage "hypothermia arm" |
| Targeted controlled temperature between 36.5 and 37.5°C | Placebo comparator | Patients will be placed in targeted temperature control between 36.5 and 37.5°C for 48 hours Receives: Biological: NSE dosage "normothermia arm" |
What is being measured
The primary outcome is the main question the study is designed to answer.
NSE level between day 1 and day 3
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion14 Jan 2018
- Study completion9 Aug 2018
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 Cardiac ArrestStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste Lascarrou, MD, Study chair, CHD Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722473
- Sponsor's protocol ID
- NSE-HYPERION
- Acronym
- NSE-HYPERION
- Status last verified
- Feb 2019
- First submitted
- 24 Mar 2016
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lascarrou JB, Miailhe AF, le Gouge A, Cariou A, Dequin PF, Reignier J, Coupez E, Quenot JP, Legriel S, Pichon N, Thevenin D, Boulain T, Frat JP, Vimeux S, Colin G, Desroys du Roure F. NSE as a predictor of death or poor neurological outcome after non-shockable cardiac arrest due to any cause: Ancillary study of HYPERION trial data. Resuscitation. 2021 Jan;158:193-200. doi: 10.1016/j.resuscitation.2020.11.035. Epub 2020 Dec 8.
PubMed 33301887
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.
- ClinicalTrials.gov ID
- NCT02722473
- Acronym / sponsor ID
- NSE-HYPERION / NSE-HYPERION
- Conditions
- Cardiac Arrest, Hypothermia, Critical Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 14 Jan 2018 (actual)
- Study completion
- 9 Aug 2018 (actual)
- First posted
- 30 Mar 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.
Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.
There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.
NSE-Ancillary Study of HYPERION Trial will determine impact on neurospecific enolase (brain biomarker) of two temperature target for targeted temperature management (33°C or 37°C) after cardiac arrest in non-shockable rhythm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted controlled temperature between 32.5 and 33.5°C | Active comparator | Biological: NSE dosage "hypothermia arm"Patients will be placed in targeted temperature control between 32.5 and 33.5°C for 24 hours and then slowly rewarmed for targeted temperature control between 36.5 and 37.5°C for 24 hours. |
| Targeted controlled temperature between 36.5 and 37.5°C | Placebo comparator | Biological: NSE dosage "normothermia arm"Patients will be placed in targeted temperature control between 36.5 and 37.5°C for 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cardiac arrest in nonshockable rhythm and
- Glasgow Coma Scale score ≤8. In patients receiving sedative therapy at ICU admission, the Glasgow Coma Scale score assessed by the emergency physician just before sedative therapy initiation is used.
- Patient must be randomized in a center which participate in the ancillary study.
Key exclusion criteria (12 listed)
- No-flow time >10 min (time from collapse to initiation of external cardiac massage);
- Low-flow time >60 min (time from initiation of external cardiac massage to return of spontaneous circulation).
- Major hemodynamic instability (defined as a continuous epinephrine or norepinephrine infusion at a flow rate >1 μg/Kg/min)
- Time from cardiac arrest to study inclusion >300 min
- Moribund patient
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 |
|---|---|---|
| NSE dosage "hypothermia arm"There 3 dosage of NSE per patient included: day 1, day 2 and day 3 during targeted temperature management between 33° and 37°C. | Biological | Targeted controlled temperature between 32.5 and 33.5°C |
| NSE dosage "normothermia arm"There 3 dosage of NSE per patient included: day 1, day 2 and day 3 during targeted temperature management at 37°C. | Biological | Targeted controlled temperature between 36.5 and 37.5°C |
Primary outcome
NSE level between day 1 and day 3
Time frame: Day 3
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 25 Feb 2019.
- Derived from this study: PubMed 33301887Lascarrou JB, Miailhe AF, le Gouge A, Cariou A, Dequin PF, Reignier J, Coupez E, Quenot JP, Legriel S, Pichon N, Thevenin D, Boulain T, Frat JP, Vimeux S, Colin G, Desroys du Roure F. NSE as a predictor of death or poor neurological outcome after non-shockable cardiac arrest due to any cause: Ancillary study of HYPERION trial data. Resuscitation. 2021 Jan;158:193-200. doi: 10.1016/j.resuscitation.2020.11.035. Epub 2020 Dec 8.
- Trial Protocol published in SJTREMLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Baptiste Lascarrou, MD study chair
CHD Vendee
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NSE dosage "hypothermia arm" and NSE dosage "normothermia arm" in people with Cardiac Arrest and Hypothermia, run by Centre Hospitalier Departemental Vendee at 14 sites in France.
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 3 inclusion and 12 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 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
NSE level between day 1 and day 3 (time frame: Day 3). 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 NCT02722473, 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 25 Feb 2019.