Neurological Prognosis Cardiac ArrestProNeCANCT03849911
EEG and SEP Evaluation for Good and Poor Neurological Prognosis After Cardiac Arrest
An observational study of Neurological Prognosis Cardiac Arrest, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
Hypoxic-Ischemic-encephalopathy (HIE) is a severe and frequent neurological complication of successful cardiopulmonary-resuscitation after cardiac arrest (CA). Prognosticating neurological outcomes in patients with HIE is challenging and recent guidelines suggest a multimodal approach. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neurological Prognosis Cardiac Arrest
- What is being tested?
- Neurophysiological Prognosis and Multimodal Prognosis for poor early neurological outcome
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2016to 1 Dec 2018
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every major patient after CA admitted to the follow intensive care unit: Careggi University Hospital (Firenze), which will be the coordinating center, San Giuseppe Hospital (Empoli), Bufalini Hospital (Cesena), Santa Maria delle Croci Hospital (Ravenna), Santa Maria NuovaHospital (Reggio Emilia), Ospedale Civile of Baggiovara (Baggiovara-Modena),Maggiore Hospital of Lodi (Lodi-Milano),San Raffaele Hospital (Milano), Ospedale Civile of Legnano (Legnano-Milano), Policlinico Umberto Primo (Roma), Santa Maria della Misericordia Hospital (Perugia), San Salvatore Hospital (L'Aquila), Galliera Hospital (Genova)
Who may be able to join
- male and female patients between 18 and 90 years of age and
- comatose patients surviving after CA with a Glasgow Coma Scale (GCS) <9
Who cannot join
- patients with surgical or traumatic causes of CA,
- patients showing contemporary presence of other neurological diseases (i.e. traumatic brain injury or brain infarction),
- patients with previous severe neurological diseases,
- patients with remote pathological anamnesis showing severe diseases with life expectancy less than 6 months,
- patients with previous severe disability,
- contemporary presence of confounding factors that hamper clinical evaluation (in particular the consciousness state)
- patients with contemporary absence of cortical response N20/P25 and lemniscal wave P14
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EEG and SEP Evaluation for Good and Poor Neurological Prognosis After Cardiac Arrest: a Prospective Multicenter Cohort Trial (proNeCA)
Hypoxic-Ischemic-encephalopathy (HIE) is a severe and frequent neurological complication of successful cardiopulmonary-resuscitation after cardiac arrest (CA). Prognosticating neurological outcomes in patients with HIE is challenging and recent guidelines suggest a multimodal approach. Only few studies have analyzed the prognostic power of the association between instrumental tests and, in addition, most of them were monocentric, retrospective and evaluating only poor outcome.
Read the detailed description
Post-anoxic encephalopathy is a severe and frequent neurological complication of successful cardiopulmonary resuscitation and it is usually responsible for coma onset in patients surviving a CA. A reliable early assessment of the neurological prognosis is an important research goal because it could address CA patient management within intensive care units (ICUs).
However, prognosticating neurological outcomes in patients with HIE is challenging and recent guidelines suggest a multimodal approach. Only few studies have analyzed the prognostic power of the association between instrumental tests and, in addition, most of them were monocentric, retrospective and evaluating only poor outcome.
Thus, the investigators designed a multicenter prospective cohort study to assessing the prognostic power of the association of electroencephalogram(EEG) and somatosensory evoked potentials(SEPs) for the prediction of both poor and good neurological outcomes at different times after CA.
The principal aim of this study will be to evaluate the prognostic power of EEG performed in comatose patients within the first 12h after CA for good outcome prediction (cerebral performance categories CPC 1-2-3) and to evaluate its prognostic power for the poor outcome prediction (CPC 4-5) when performed at 24 and 72h after CA.
Moreover, the investigators will aim to evaluate if the combination of EEG and SEPs will allow to correctly identify a greater number of patients with both poor and good outcomes (when performed within the first 12h) and with poor outcomes (when performed after 72h) compared with the use of only a single test. In addition, the investigators will evaluate if the concordance of EEG/SEP patterns will increase the prognostic reliability obtained with a single test.
Finally, the investigators will aim to confirm if the prognostic power of the bilaterally absent(AA) SEP pattern for poor outcome prediction will be reliable at any time of recording after CA, and if other SEP pathological patterns will assume an analogous ominous prognostic significance.
ADDENDUM: after the conclusion of the enrollment we investigated the availability of brain CT data obtained within the first 24 hours after CA. In 7 over 13 centers, including the coordinator center (AOU Careggi, Florence) early brain CT data were available.
- Conditions
- Neurological Prognosis Cardiac Arrest
- Being tested
- Neurophysiological Prognosis, Multimodal Prognosis for poor early neurological outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurophysiological PrognosisDiagnostic test
SEP and EEG evaluation for Neurological Prognosis of Cardiac Arrest
Multimodal Prognosis for poor early neurological outcomeDiagnostic test
Brain CT, SEP and EEG evaluation
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Performance Categories
Neurological outcome will be the primary outcome measure and it will be assessed at 6 months after CA using CPC as follows: CPC 1, no or minor neurological deficits; CPC 2, moderate disability; CPC 3, severe disability; CPC 4, unresponsive wakefulness state and CPC 5, death. Neurological outcome will be dichotomized into 'good' (CPC 1-3) and 'poor' (CPC 4-5) outcomes
Measured: Month 6
Secondary outcomes (3)
Electroencephalography, EEG
American Clinical Neurophysiology Society (ACNS) EEG terminology
Measured: hour: 12-24-72
Somatosensory Evoked Potentials, SEP
According to the cortical responses of each hemisphere
Measured: hour: 12-24-72
Brain CT
Caudate nucleus(CN), putamen(PU) and posterior limb of the internal capsule(PIC) were bilaterally identified as circular (0.6cm2) regions of interest(ROIs) where density measurement (Hounsfield Units-HU) were performed. At the corpus callosum(CC) level, the density value was considered the same bilaterally. The GM/WM ratio at basal ganglia level was calculated as follows: GM/WM ratio= (CN+PU)/(CC+PIC)
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Jun 2016
- Primary completion1 Jun 2018
- Study completion1 Dec 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 Neurological Prognosis 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonello Grippo, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849911
- Sponsor's protocol ID
- AOU Careggi
- Acronym
- ProNeCA
- Status last verified
- Apr 2019
- First submitted
- 18 Feb 2019
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scarpino M, Lolli F, Lanzo G, Carrai R, Spalletti M, Valzania F, Lombardi M, Audenino D, Contardi S, Grazia Celani M, Marrelli A, Mecarelli O, Minardi C, Minicucci F, Politini L, Vitelli E, Peris A, Amantini A, Grippo A, Sandroni C; ProNeCA Study Group. Do changes in SSEP amplitude over time predict the outcome of comatose survivors of cardiac arrest? Resuscitation. 2022 Dec;181:133-139. doi: 10.1016/j.resuscitation.2022.10.025. Epub 2022 Nov 12.
PubMed 36375653
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG and SEP Evaluation for Good and Poor Neurological Prognosis After Cardiac Arrest: a Prospective Multicenter Cohort Trial (proNeCA)
- ClinicalTrials.gov ID
- NCT03849911
- Acronym / sponsor ID
- ProNeCA / AOU Careggi
- Conditions
- Neurological Prognosis Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 21 Feb 2019 (actual)
- 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.
Hypoxic-Ischemic-encephalopathy (HIE) is a severe and frequent neurological complication of successful cardiopulmonary-resuscitation after cardiac arrest (CA). Prognosticating neurological outcomes in patients with HIE is challenging and recent guidelines suggest a multimodal approach. Only few studies have analyzed the prognostic power of the association between instrumental tests and, in addition, most of them were monocentric, retrospective and evaluating only poor outcome.
Detailed description
Post-anoxic encephalopathy is a severe and frequent neurological complication of successful cardiopulmonary resuscitation and it is usually responsible for coma onset in patients surviving a CA. A reliable early assessment of the neurological prognosis is an important research goal because it could address CA patient management within intensive care units (ICUs).
However, prognosticating neurological outcomes in patients with HIE is challenging and recent guidelines suggest a multimodal approach. Only few studies have analyzed the prognostic power of the association between instrumental tests and, in addition, most of them were monocentric, retrospective and evaluating only poor outcome.
Thus, the investigators designed a multicenter prospective cohort study to assessing the prognostic power of the association of electroencephalogram(EEG) and somatosensory evoked potentials(SEPs) for the prediction of both poor and good neurological outcomes at different times after CA.
The principal aim of this study will be to evaluate the prognostic power of EEG performed in comatose patients within the first 12h after CA for good outcome prediction (cerebral performance categories CPC 1-2-3) and to evaluate its prognostic power for the poor outcome prediction (CPC 4-5) when performed at 24 and 72h after CA.
Moreover, the investigators will aim to evaluate if the combination of EEG and SEPs will allow to correctly identify a greater number of patients with both poor and good outcomes (when performed within the first 12h) and with poor outcomes (when performed after 72h) compared with the use of only a single test. In addition, the investigators will evaluate if the concordance of EEG/SEP patterns will increase the prognostic reliability obtained with a single test.
Finally, the investigators will aim to confirm if the prognostic power of the bilaterally absent(AA) SEP pattern for poor outcome prediction will be reliable at any time of recording after CA, and if other SEP pathological patterns will assume an analogous ominous prognostic significance.
ADDENDUM: after the conclusion of the enrollment we investigated the availability of brain CT data obtained within the first 24 hours after CA. In 7 over 13 centers, including the coordinator center (AOU Careggi, Florence) early brain CT data were available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every major patient after CA admitted to the follow intensive care unit: Careggi University Hospital (Firenze), which will be the coordinating center, San Giuseppe Hospital (Empoli), Bufalini Hospital (Cesena), Santa Maria delle Croci Hospital (Ravenna), Santa Maria NuovaHospital (Reggio Emilia), Ospedale Civile of Baggiovara (Baggiovara-Modena),Maggiore Hospital of Lodi (Lodi-Milano),San Raffaele Hospital (Milano), Ospedale Civile of Legnano (Legnano-Milano), Policlinico Umberto Primo (Roma), Santa Maria della Misericordia Hospital (Perugia), San Salvatore Hospital (L'Aquila), Galliera Hospital (Genova)
Key inclusion criteria (2 listed)
- male and female patients between 18 and 90 years of age and
- comatose patients surviving after CA with a Glasgow Coma Scale (GCS) <9
Key exclusion criteria (7 listed)
- patients with surgical or traumatic causes of CA,
- patients showing contemporary presence of other neurological diseases (i.e. traumatic brain injury or brain infarction),
- patients with previous severe neurological diseases,
- patients with remote pathological anamnesis showing severe diseases with life expectancy less than 6 months,
- patients with previous severe disability,
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 |
|---|---|---|
| Neurophysiological PrognosisSEP and EEG evaluation for Neurological Prognosis of Cardiac Arrest | Diagnostic test | – |
| Multimodal Prognosis for poor early neurological outcomeBrain CT, SEP and EEG evaluation | Diagnostic test | – |
Primary outcome
Cerebral Performance Categories
Time frame: Month 6
Neurological outcome will be the primary outcome measure and it will be assessed at 6 months after CA using CPC as follows: CPC 1, no or minor neurological deficits; CPC 2, moderate disability; CPC 3, severe disability; CPC 4, unresponsive wakefulness state and CPC 5, death. Neurological outcome will be dichotomized into 'good' (CPC 1-3) and 'poor' (CPC 4-5) outcomes
3 secondary outcomes
Electroencephalography, EEG
Time frame: hour: 12-24-72
Somatosensory Evoked Potentials, SEP
Time frame: hour: 12-24-72
Brain CT
Time frame: within 24 hours
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 30 Apr 2019.
- Derived from this study: PubMed 36375653Scarpino M, Lolli F, Lanzo G, Carrai R, Spalletti M, Valzania F, Lombardi M, Audenino D, Contardi S, Grazia Celani M, Marrelli A, Mecarelli O, Minardi C, Minicucci F, Politini L, Vitelli E, Peris A, Amantini A, Grippo A, Sandroni C; ProNeCA Study Group. Do changes in SSEP amplitude over time predict the outcome of comatose survivors of cardiac arrest? Resuscitation. 2022 Dec;181:133-139. doi: 10.1016/j.resuscitation.2022.10.025. Epub 2022 Nov 12.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Prognosis Cardiac Arrest, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
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 2 inclusion and 7 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 30 Apr 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 Italy. 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?
Cerebral Performance Categories (time frame: Month 6). 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 NCT03849911, 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 30 Apr 2019.