Out-Of-Hospital Cardiac ArrestBIMOPECANCT03873662
Biochemical Makers for Outcome After Pediatric out-of Hospital Cardiac Arrest
An observational study of Out-Of-Hospital Cardiac Arrest, run by Brno University Hospital at 1 site in Czechia.
Trial summary
This single-center study will validate serum, imaging and clinical markers to determine outcome of pediatric patients early after Out-of-Hospital cardiac arrest (OHCA). Results are expected to add to the field of postresuscitation care of these children. Read more about this study
- Who is it for?
- Ages 14 days to 19 years
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Blood sample
- Type of treatment
- Injection or infusion
- How many people
- 4 participants
- Where
- 1 siteCzechia
- Study dates
- 17 May 2019to 31 Oct 2020
- 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 14 days to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients after out-of hospital cardiac arrest admitted to Departemnt of pediatric anesthesia and intensive care
Who may be able to join
- Children between 2 weeks -18 years of age
- Child who suffered an out of hospital CA: defined as "Cessation of cardiac mechanical activity as confirmed by the absence of signs of circulation. Includes the following rhythms: pulseless electrical activity (PEA), asystole, ventricular tachycardia, and ventricular fibrillation" with the need od chest compressions.
- Children admitted to the Department of pediatric anesthesia and intensive care
- Children have vascular access for blood draws as part of their standard of care
- Children have a pre-CA Pediatric Cerebral Performance Category (PCPC) score of 1- 3.
Who cannot join
- Patients with brain injury of other etiologies. (trauma, abscess, tumor, bacterial meningitis)
- Children with do not resuscitate (DNR) status
- Pregnancy
- Metabolic or other disease affecting the brain (eg. refractory epilepsy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biochemical Makers for Outcome Prognostication After Pediatric out-of Hospital Cardiac Arrest: Observational Cohort Trial
This single-center study will validate serum, imaging and clinical markers to determine outcome of pediatric patients early after Out-of-Hospital cardiac arrest (OHCA). Results are expected to add to the field of postresuscitation care of these children. The validation of markers will provide clinicians with the tools to assess the severity of neurological impairment after hypoxic injury to the brain early after OHCA.
Read the detailed description
Cardiac arrest (CA) is an important cause of mortality and morbidity in pediatric patients. Yearly incidence of CA is 7- 8 cases per 100000 children. Hypoxia is the leading cause of OHCA with up to 1/3 being of respiratory origin, and drowning in ¼ of cases. Up to 2/3 of children admitted to hospitals after OHCA die, with only 16,2% survivors with good neurological outcome. Pediatric cerebral performance category (pCPC) 5, which means persistent coma with patent brainstem reflexes or president vegetative state, or pCPC 6 -brain death is considered a bad outcome in pediatric OHCA survivors.
Early prediction of poor outcome is desirable to avoid futile care and to guide the communication with the relatives of the patient.
There is no published recommendation for the prognostication of outcome of comatose pediatric cardiac arrest survivors. The recommendations for adult patients contains the use of neuron-specific enolase (NSE) and protein S-100B in combination with further predictors in prognosticating the outcome of CA. The remaining problem is to determine a cut-off value, to predict poor outcome (CPC category 5 and 6) with 100% specificity. For this reason, the cut-off values are not included in the recommendations.
Neuron-specific enolase is a glycolytic enzyme localized primarily in the cytoplasma of the neurons. The protein S-100B is a calcium-binding protein specific for the astroglia. Both are sensitive and specific markers for neuronal, respectively astroglial cell death. According to data available in the adult population, serum concentration of NSE and S100B are sensitive and specific markers of traumatic brain injury. High concentration of NSE 3 days after cardiac arrest is a strong predictor of poor outcome. Data regarding the prognostic value of neuronal biomarkers in comatose pediatric CA survivors are scarce.
The aim of the pilot study is to determine the association of the concentration of neuronal biomarkers and the outcome of pediatric CA survivors admitted to the pediatric ICU of the University Hospital Brno. The association will be evaluated individually and in combination with clinical and imaging variables. The basic hypothesis is, that the biochemical, clinical and imaging markers of neurological injury are able to prognosticate poor outcome (pCPC 5-6) with high sensitivity and specificity. The innovation of the study will be the evaluation of the dynamics of serum biomarkers early after CA (first 48 hours).
This is a prospective observational study. All consecutive patients admitted to the ICU of the University Hospital Brno after OHCA and cardiopulmonary resuscitation (CPR), whose parents sign an informed consent will be included. In case the parents will not be present at the time the patient will be admitted, an independent physician will wigh the consent, and the parents consent will be obtained as soon as possible. In case of waiver of consent, the samples will not be included in the final analysis and the patient will be excluded from the study. Patients will be treated according to the actual Guidelines for postresuscitation care. Patients will be treated according to the international guidelines for postresuscitation care. Demographic data will be recorded according to the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest, previously used for the reporting of data on pediatric CA survivors. Clinical parameters, previously shown to be associated with outcomes of patients after OHCA will be recorded. These include: neurological status (level of consciousness as Glasgow coma scale (GCS), reaction of pupils to light, corneal reflex, presence of myoclonus).
Biochemical markers will be recorded as follows: as soon as possible after the arrival of the patient and insertion of a intravenous line, blood will be drawn for the analysis of arterial blood gases, which are a standard test in patients admitted to emergency department. Blood will be analysed in a bed-side analyzer. Serum lactate and base-excess (BE) will be documented from this blood sample. Another blood sample will be drawn parallelly for biochemical tests which will be sent to the laboratory. These tests standard in patients admitted to emergency department. Serum concentration of NSE and S100B protein will be analysed and recorded from this sample. A sample of blood for the evaluation of the early dynamics of the serum concentration of NSE and S100B will be redrawn after 12 and 48/24 hours after admitting the patient.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Blood sample
- Keywords
- Out-Of-Hospital Cardiac Arrest, Pediatric patient, Outcome, Prognostication, Neurologic outcome
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Also called Blood biochemical makers analysis
Biochemical markers will be recorded as follows: as soon as possible after the arrival of the patient and insertion of a intravenous line, blood will be drawn for the analysis of arterial blood gases, which are a standard test in patients admitted to emergency department. Blood will be analysed in a bed-side analyzer. Serum lactate and base-excess (BE) will be documented from this blood sample. Another blood sample will be drawn parallelly for biochemical tests which will be sent to the laboratory. These tests standard in patients admitted to emergency department. Serum concentration of NSE and S100B protein will be analysed and recorded from this sample. A sample of blood for the evaluation of the early dynamics of the serum concentration of NSE and S100B will be redrawn after 12 and 48/24 hours after admitting the patient.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients after out-of hospital cardiac arrest | Pediatric patients after out-of hospital cardiac arrest admitted to Department of pediatric anesthesia and intensive care University hospital in Brno in selected study period with blood sample analysis for neurologic outcome prognostication Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric cerebral performance category
To evaluate the serum levels of NSE and S100B during first 7 days of hospitalization to determine poor outcome at 1 year post-CA defined as pCPC 5-6
Measured: One year from cardiac arrest
Pediatric cerebral performance category
To evaluate the serum levels of NSE and S100B during first 7 days of hospitalization to determine poor outcome at 3 months post-CA defined as pCPC 5-6
Measured: 3 months from cardiac arrest
Secondary outcomes (1)
Pediatric cerebral performance category
To evaluate the association between early dynamics (24 hours from admission) of serum concentration of NSE and S100B in OHCA pediatric patients and Pediatric cerebral performance category scale at 3 months
Measured: 3 months from cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start17 May 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Why it stopped: Low inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Stourac, assoc.Prof.MD.Ph.D, Study chair, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873662
- Sponsor's protocol ID
- Biomarkers KDAR 2019
- Acronym
- BIMOPECA
- Status last verified
- Nov 2020
- First submitted
- 3 Mar 2019
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Makers for Outcome Prognostication After Pediatric out-of Hospital Cardiac Arrest: Observational Cohort Trial
- ClinicalTrials.gov ID
- NCT03873662
- Acronym / sponsor ID
- BIMOPECA / Biomarkers KDAR 2019
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Out-Of-Hospital Cardiac Arrest, Pediatric patient, Outcome, Prognostication, Neurologic outcome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low inclusion rate
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 17 May 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 13 Mar 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.
This single-center study will validate serum, imaging and clinical markers to determine outcome of pediatric patients early after Out-of-Hospital cardiac arrest (OHCA). Results are expected to add to the field of postresuscitation care of these children. The validation of markers will provide clinicians with the tools to assess the severity of neurological impairment after hypoxic injury to the brain early after OHCA.
Detailed description
Cardiac arrest (CA) is an important cause of mortality and morbidity in pediatric patients. Yearly incidence of CA is 7- 8 cases per 100000 children. Hypoxia is the leading cause of OHCA with up to 1/3 being of respiratory origin, and drowning in ¼ of cases. Up to 2/3 of children admitted to hospitals after OHCA die, with only 16,2% survivors with good neurological outcome. Pediatric cerebral performance category (pCPC) 5, which means persistent coma with patent brainstem reflexes or president vegetative state, or pCPC 6 -brain death is considered a bad outcome in pediatric OHCA survivors.
Early prediction of poor outcome is desirable to avoid futile care and to guide the communication with the relatives of the patient.
There is no published recommendation for the prognostication of outcome of comatose pediatric cardiac arrest survivors. The recommendations for adult patients contains the use of neuron-specific enolase (NSE) and protein S-100B in combination with further predictors in prognosticating the outcome of CA. The remaining problem is to determine a cut-off value, to predict poor outcome (CPC category 5 and 6) with 100% specificity. For this reason, the cut-off values are not included in the recommendations.
Neuron-specific enolase is a glycolytic enzyme localized primarily in the cytoplasma of the neurons. The protein S-100B is a calcium-binding protein specific for the astroglia. Both are sensitive and specific markers for neuronal, respectively astroglial cell death. According to data available in the adult population, serum concentration of NSE and S100B are sensitive and specific markers of traumatic brain injury. High concentration of NSE 3 days after cardiac arrest is a strong predictor of poor outcome. Data regarding the prognostic value of neuronal biomarkers in comatose pediatric CA survivors are scarce.
The aim of the pilot study is to determine the association of the concentration of neuronal biomarkers and the outcome of pediatric CA survivors admitted to the pediatric ICU of the University Hospital Brno. The association will be evaluated individually and in combination with clinical and imaging variables. The basic hypothesis is, that the biochemical, clinical and imaging markers of neurological injury are able to prognosticate poor outcome (pCPC 5-6) with high sensitivity and specificity. The innovation of the study will be the evaluation of the dynamics of serum biomarkers early after CA (first 48 hours).
This is a prospective observational study. All consecutive patients admitted to the ICU of the University Hospital Brno after OHCA and cardiopulmonary resuscitation (CPR), whose parents sign an informed consent will be included. In case the parents will not be present at the time the patient will be admitted, an independent physician will wigh the consent, and the parents consent will be obtained as soon as possible. In case of waiver of consent, the samples will not be included in the final analysis and the patient will be excluded from the study. Patients will be treated according to the actual Guidelines for postresuscitation care. Patients will be treated according to the international guidelines for postresuscitation care. Demographic data will be recorded according to the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest, previously used for the reporting of data on pediatric CA survivors. Clinical parameters, previously shown to be associated with outcomes of patients after OHCA will be recorded. These include: neurological status (level of consciousness as Glasgow coma scale (GCS), reaction of pupils to light, corneal reflex, presence of myoclonus).
Biochemical markers will be recorded as follows: as soon as possible after the arrival of the patient and insertion of a intravenous line, blood will be drawn for the analysis of arterial blood gases, which are a standard test in patients admitted to emergency department. Blood will be analysed in a bed-side analyzer. Serum lactate and base-excess (BE) will be documented from this blood sample. Another blood sample will be drawn parallelly for biochemical tests which will be sent to the laboratory. These tests standard in patients admitted to emergency department. Serum concentration of NSE and S100B protein will be analysed and recorded from this sample. A sample of blood for the evaluation of the early dynamics of the serum concentration of NSE and S100B will be redrawn after 12 and 48/24 hours after admitting the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients after out-of hospital cardiac arrest | – | Diagnostic Test: Blood samplePediatric patients after out-of hospital cardiac arrest admitted to Department of pediatric anesthesia and intensive care University hospital in Brno in selected study period with blood sample analysis for neurologic outcome prognostication |
Who may qualify
- Ages
- 14 days to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients after out-of hospital cardiac arrest admitted to Departemnt of pediatric anesthesia and intensive care
Key inclusion criteria (5 listed)
- Children between 2 weeks -18 years of age
- Child who suffered an out of hospital CA: defined as "Cessation of cardiac mechanical activity as confirmed by the absence of signs of circulation. Includes the following rhythms: pulseless electrical activity (PEA), asystole, ventricular tachycardia, and ventricular fibrillation" with the need od chest compressions.
- Children admitted to the Department of pediatric anesthesia and intensive care
- Children have vascular access for blood draws as part of their standard of care
- Children have a pre-CA Pediatric Cerebral Performance Category (PCPC) score of 1- 3.
Key exclusion criteria (4 listed)
- Patients with brain injury of other etiologies. (trauma, abscess, tumor, bacterial meningitis)
- Children with do not resuscitate (DNR) status
- Pregnancy
- Metabolic or other disease affecting the brain (eg. refractory epilepsy)
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 |
|---|---|---|
| Blood sampleAlso: Blood biochemical makers analysisBiochemical markers will be recorded as follows: as soon as possible after the arrival of the patient and insertion of a intravenous line, blood will be drawn for the analysis of arterial blood gases, which are a standard test in patients admitted to emergency department. Blood will be analysed in a bed-side analyzer. Serum lactate and base-excess (BE) will be documented from this blood sample. Another blood sample will be drawn parallelly for biochemical tests which will be sent to the laboratory. These tests standard in patients admitted to emergency department. Serum concentration of NSE and S100B protein will be analysed and recorded from this sample. A sample of blood for the evaluation of the early dynamics of the serum concentration of NSE and S100B will be redrawn after 12 and 48/24 hours after admitting the patient. | Diagnostic test | Pediatric patients after out-of hospital cardiac arrest |
Primary outcome
Pediatric cerebral performance category
Time frame: One year from cardiac arrest
To evaluate the serum levels of NSE and S100B during first 7 days of hospitalization to determine poor outcome at 1 year post-CA defined as pCPC 5-6
Pediatric cerebral performance category
Time frame: 3 months from cardiac arrest
To evaluate the serum levels of NSE and S100B during first 7 days of hospitalization to determine poor outcome at 3 months post-CA defined as pCPC 5-6
1 secondary outcome
Pediatric cerebral performance category
Time frame: 3 months from cardiac arrest
Results and safety
The study was stopped early (reason given: Low inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- 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.
Petr Stourac, assoc.Prof.MD.Ph.D study chair
Brno University Hospital
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 Out-Of-Hospital Cardiac Arrest, run by Brno University Hospital at 1 site in Czechia.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 30 Nov 2020. 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 Czechia. 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 was stopped early (reason given: Low inclusion rate). Results are not available in the source record.
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?
Pediatric cerebral performance category (time frame: One year from cardiac arrest). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2020.