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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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.

Czechia1 site
  • University hospital Brno

    Brno, State, 62500

Other trials in Czechia

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.

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 groups in NCT03873662
Study groupRoleWhat they receive
Pediatric patients after out-of hospital cardiac arrestPediatric 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.

  1. 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

  2. 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)
  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.

  1. First posted13 Mar 2019
  2. Study start17 May 2019
  3. Primary completion31 Oct 2020
  4. Study completion31 Oct 2020

Why it stopped: Low inclusion rate

Resources

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)
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

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.

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