Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03873662 |
| Other study ID # |
Biomarkers KDAR 2019 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 17, 2019 |
| Est. completion date |
October 31, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Brno University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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 ΒΌ 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.
