Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN)

Cardiac Arrest Clinical Trial

— PACHIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04675918
• Other study ID #: ESCE-RCP 2.0
• Secondary ID: PI18/01632
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2021
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2028
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• In-hospital Cardiac Arrest
• Pediatric ALL

Intervention

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

Locations

Country	Name	City	State
Spain	Gregorio Marañon Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Jimena del Castillo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival	Through study completition an average of 3 years
Secondary	Neurological outcome	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.	5 years