Cardiac ArrestPACHINNCT04675918
Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN)
An observational study of Cardiac Arrest and Pediatric ALL, run by Jimena del Castillo at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cardiac Arrest, Pediatric ALL, In-hospital Cardiac Arrest
- What is being tested?
- Cardiac arrest
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients who suffer a cardiac arrest in hospital premises and are resuscitated with at least 1 minute of cardiopulmonary resuscitation measures.
Who may be able to join
- all children aged 1 month to 18 years who suffer a CA in hospital
Who cannot join
- Patients being treated with extracorporeal circulatory support (ECMO or ventricular assistance) at the time of CA.
- Duration of resuscitation < 1minute
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Gregorio Marañon Hospital
Madrid, 28009
Jimena del Castillo, MD PhD, +34 630445620, jimenadelcastillo@yahoo.es
Jesús López-Herce, MD PhD
About this study
Official title: Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN): a Prospective International Multicenter Register of Cardiac Arrest in Children.
: 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
Read the 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.
- Conditions
- Cardiac Arrest, Pediatric ALL, In-hospital Cardiac Arrest
- Being tested
- Cardiac arrest
- Keywords
- pediatric cardiac arrest, outcomes, survival, cardiopulmonary resuscitation
- Medical subject headings
- Heart Arrest, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac arrestProcedure or surgery
Definition of characteristics of cardiac arrest and resuscitation as well as post-resuscitational care and follow up.
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival
Measured: Through study completition an average of 3 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Feb 2021 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Jimena del Castillo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jimena del Castillo, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675918
- Sponsor's protocol ID
- ESCE-RCP 2.0
- Other IDs
- PI18/01632
- Acronym
- PACHIN
- Status last verified
- Jan 2021
- First submitted
- 27 Nov 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34332522