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

NCT03873662 | Terminated DMC

• 1 other identifier: Biomarkers KDAR 2019
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Out-Of-Hospital Cardiac Arrest; Pediatric patient; Outcome; Prognostication; Neurologic outcome

Outcome Measures

Primary Outcomes (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 1 year post-CA defined as pCPC 5-6

  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

  3 months from cardiac arrest

Secondary Outcomes (1)

• Pediatric cerebral performance category

  3 months from cardiac arrest

Other Outcomes (1)

• Early dynamics of neuronal biomarkers NSE and S100B and association with neurologic outcome

  12 months from cardiac arrest

Study Arms (1)

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

Interventions

Blood sample DIAGNOSTIC_TEST

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.

Also known as: Blood biochemical makers analysis

Pediatric patients after out-of hospital cardiac arrest

Eligibility Criteria

• Age: 14 Days - 19 Years
• Gender Eligibility Details: Pediatric patient after out-of hospital cardiac arrest
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients after out-of hospital cardiac arrest admitted to Departemnt of pediatric anesthesia and intensive care

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University hospital Brno

Brno, State, 62500, Czechia

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Petr Stourac, assoc.Prof.MD.Ph.D

  University Hospital Brno

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc.prof.MD,Ph.D

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 13, 2019
• Study Start: May 17, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

CZ (1)