Versailles Hospital Cardiac Arrest Registry

Cardiac Arrest Clinical Trial

Official title:

Versailles Hospital Cardiac Arrest Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03594318
• Other study ID #: P13/20_ACR
• Status: Recruiting
• Start date: January 2006
• Est. completion date: December 2030

Study information

• Verified date: July 2018
• Source: Versailles Hospital
• Contact: Legriel Stephane, MD
• Email: slegriel[@]ch-versailles.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Out-of-hospital and in-hospital cardiac arrest (CA) requiring intensive care unit management.

Data collection using a standardized form : demographic data and data related to the CA according to the Utstein guidelines.. Circumstances of onset, dates and times of onset and control of abnormal movements (myoclonus and.or seizures).

On-scene clinical findings, pre-hospital and hospital care providers, timing of various treatments and supportive care, results of etiological investigations, cause of CA. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Cerebral Performance Category scale score at ICU and hospital discharge, day-90 and 1-year after CA and determined based on data in the ICU and/or hospital/neurologist charts and/or general practitionner phone interview.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2030
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cardiac arrest requiring Intensive Care Unit management

• Age >= 18 years

Exclusion Criteria:

• Refusal to participate

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Locations

Country	Name	City	State
France	CH Versailles	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term favorable outcome	A favorable outcome is defined by a Cerebral Performance Category scale score (CPC) of 1 or 2. The Cerebral Performance Category scale score will be determined according to hospital charts and/or general practitioner phone interview.; The CPC score : [5: Death, 4: Persistent vegetative state, 3: Severe disability, 2: Moderate disability, 1 : Low disability]	1 year
Secondary	Short term favorable outcome	A favorable outcome is defined by a Cerebral Performance Category scale score (CPC) of 1 or 2. The Cerebral Performance Category scale score will be determined according to hospital charts and/or general practitioner phone interview.; The CPC score : [5: Death, 4: Persistent vegetative state, 3: Severe disability, 2: Moderate disability, 1 : Low disability]	3 months
Secondary	Postanoxic Status Epilepticus	Postanoxic Status Epilepticus occurence as defined by EEG abnormalities based on the Salzburg Criteria	28 days
Secondary	Complications of anticoagulant/ antiplatelet therapies	Any bleeding requiring >2 Units Red Blood Cell transfusion	28 days
Secondary	Short term quality of life as assessed by the Short Form (36) Health Survey (SF36)	Description of global SF36 score and each of its eight sections (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health).	3 months
Secondary	Long term quality of life as assessed by the Short Form (36) Health Survey (SF36)	Description of global SF36 score and each of its eight sections (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health).	1 year