- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04675918
Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN) (PACHIN)
Pediatric In-Hospital Cardiac Arrest International Registry (PACHIN): a Prospective International Multicenter Register of Cardiac Arrest in Children.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Madrid, Spain, 28009
- Recruiting
- Gregorio Marañón Hospital
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Contact:
- Jimena del Castillo, MD PhD
- Phone Number: +34 630445620
- Email: jimenadelcastillo@yahoo.es
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Principal Investigator:
- Jesús López-Herce, MD PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival
Time Frame: Through study completition an average of 3 years
|
Survival
|
Through study completition an average of 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESCE-RCP 2.0
- PI18/01632 (Other Grant/Funding Number: ISCIII)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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