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Biochemical Makers for Outcome After Pediatric out-of Hospital Cardiac Arrest (BIMOPECA)

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ClinicalTrials.gov Identifier: NCT03873662
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Petr Štourač, MD, Brno University Hospital

Brief 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.

Condition or disease Intervention/treatment
Out-Of-Hospital Cardiac Arrest Diagnostic Test: Blood sample

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biochemical Makers for Outcome Prognostication After Pediatric out-of Hospital Cardiac Arrest: Observational Cohort Trial
Actual Study Start Date : May 17, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Diagnostic Test: Blood sample
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.
Other Name: Blood biochemical makers analysis




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Pediatric cerebral performance category [ Time Frame: 3 months from cardiac arrest ]
    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


Other Outcome Measures:
  1. Early dynamics of neuronal biomarkers NSE and S100B and association with neurologic outcome [ Time Frame: 12 months from cardiac arrest ]
    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 12 months



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Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pediatric patient after out-of hospital cardiac arrest
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients after out-of hospital cardiac arrest admitted to Departemnt of pediatric anesthesia and intensive care
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873662


Contacts
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Contact: Petr Stourac, assoc.Prof.MD.Ph.D 532234404 ext 00420 Stourac.Petr@fnbrno.cz
Contact: Jozef Klucka, MD 532234696 ext 00420 Klucka.jozef@fnbrno.cz

Locations
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Czechia
University hospital Brno Recruiting
Brno, State, Czechia, 62500
Contact: Jozef Klučka, MD    532234696 ext 00420    Klucka.jozef@fnbrno.cz   
Sponsors and Collaborators
Brno University Hospital
Investigators
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Study Chair: Petr Stourac, assoc.Prof.MD.Ph.D University Hospital Brno

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Responsible Party: Petr Štourač, MD, assoc.prof.MD,Ph.D, Brno University Hospital
ClinicalTrials.gov Identifier: NCT03873662    
Other Study ID Numbers: Biomarkers KDAR 2019
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Petr Štourač, MD, Brno University Hospital:
Out-Of-Hospital Cardiac Arrest
Pediatric patient
Outcome
Prognostication
Neurologic outcome
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases