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Clinical Trials/NCT04675918
NCT04675918
Recruiting
Not Applicable

Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN): a Prospective International Multicenter Register of Cardiac Arrest in Children.

Jimena del Castillo1 site in 1 country500 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Arrest
Sponsor
Jimena del Castillo
Enrollment
500
Locations
1
Primary Endpoint
Survival
Status
Recruiting
Last Updated
5 years ago

Overview

Brief Summary

: An intrahospital CA data recording protocol has been designed following the Utstein model. Database is hosted according to European legislation regarding patient data protection. It is drafted in English and Spanish. Invitation to participate has been sent to Spanish, European and Latinamerican hospitals. Variables included, asses hospital characteristics, the resuscitation team, patient's demographics and background, CPR, post-resuscitation care, mortality, survival and long-term evolution. Survival at hospital discharge will be evaluated as a primary outcome and survival with good neurological status as a secondary outcome, analyzing the different factors involved in them

Detailed Description

Study design: this study is a multicenter, international, prospective observational registry. Setting: patients will be enrolled by participating investigators from European and Latinamerican countries. All sites are susceptible of treating pediatric cardiac arrest patients. Participating hospitals differ in levels of care but are all able to submit their data to the study's database. Patient elegibility: Inclusion criteria: all children aged 1 month to 18 years who suffer a CA in hospital. For the study, CA is defined as the absence of vital signs requiring at least one minute of chest compressions. Subsequent episodes of CA may be included for the same individual. Exclusion criteria: Patients being treated with extracorporeal circulatory support (ECMO or ventricular assistance) at the time of CA. Patients who suffer a cardiac arrest and require ECMO for ROSC, after performing conventional CPR, will not be excluded. Duration of the data collection period 24 months. Recruitment: Study candidates will be identified by a study physician, who will explain the study to parents or guardians. Written informed consent will be obtained from parents or guardians prior to inclusion in the study. A CONSORT (Consolidated Standard of Reporting Trials) flow diagram is shown in Figure 1. Data collection: data will be collected, verified, and uploaded to a protected electronic web-based database (Xolomon) by their designated site coordinators/investigators under the oversight of their IRB. Database has been designed following the Utstein model (19). Database is hosted according to European legislation regarding patient data protection. It is drafted in English and Spanish.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
December 31, 2028
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Jimena del Castillo
Responsible Party
Sponsor Investigator
Principal Investigator

Jimena del Castillo

MD, PhD

Hospital General Universitario Gregorio Marañon

Eligibility Criteria

Inclusion Criteria

  • all children aged 1 month to 18 years who suffer a CA in hospital

Exclusion Criteria

  • Patients being treated with extracorporeal circulatory support (ECMO or ventricular assistance) at the time of CA.
  • Duration of resuscitation \< 1minute

Outcomes

Primary Outcomes

Survival

Time Frame: Through study completition an average of 3 years

Survival

Secondary Outcomes

  • Neurological outcome(5 years)

Study Sites (1)

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