Clinical trial NCT04675918: Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN)
Official title: Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN): a Prospective International Multicenter Register of Cardiac Arrest in Children.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Pediatric ALL
In-hospital Cardiac Arrest
Keywords: pediatric cardiac arrest
outcomes
survival
cardiopulmonary resuscitation
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who suffer a cardiac arrest in hospital premises and are resuscitated with at least 1 minute of cardiopulmonary resuscitation measures.

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.

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

Primary outcomes:
measure: Survival
timeFrame: Through study completition an average of 3 years
Secondary outcomes:
measure: Neurological outcome
timeFrame: 5 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gregorio Marañon Hospital
Study officials:
References:
citation: Del Castillo J, Sanz D, Herrera L, Lopez-Herce J; Grupo de Estudio de Parada Cardiaca Intrahospitalaria en la Infancia. Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN): protocol for a prospective international multicenter register of cardiac arrest in children. BMC Cardiovasc Disord. 2021 Jul 31;21(1):365. doi: 10.1186/s12872-021-02173-5.