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NCT Number: NCT04675918

Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN)

: 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

Recruiting

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gregorio Marañon Hospital

Madrid, 28009, Spain

Location status: Recruiting

Location contact

Jesús López-Herce, MD PhD

PRINCIPAL_INVESTIGATOR

Jimena del Castillo, MD PhD

CONTACT

[email protected]

+34 630445620

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac arrest

Procedure

Definition of characteristics of cardiac arrest and resuscitation as well as post-resuscitational care and follow up.

Primary outcomes

  1. Survival

    Time frame: Through study completition an average of 3 years

    Survival

Secondary outcomes

  1. Neurological outcome

    Time frame: 5 years

    Neurological outcome (Scales: Pediatric Cerecral Performance Category Scale and Pediatric Overall Performance Category Scale. Assesment of neurological outcome with both scales which attempt to measure the same items in neurological development in pediatric patients. Values of 1 or 2 describe normal recovery whilst values of 5-6 define brain death.

Sponsors and collaborators

Lead sponsor

Jimena del Castillo

Other

Registry information

Official study title

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

Acronym: PACHIN

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Dec 19, 2020
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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