Resuscitation Registry - Surrogate Markers of Outcome After Cardiac Arrest

Cardiac Arrest Clinical Trial

— CPR  

Official title:

Prospective Registry of Cardiopulmonary Arrest Survivors - Surrogate Markers for Prognostication of Outcome After Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722460
• Other study ID #: KEK BE 116/15
• Status: Completed
• Start date: January 2016
• Est. completion date: June 2022

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of the study is to determine surrogate markers for prognostication of unfavorable outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. These patients are comatose. Conscious patients are unsuitable for prognostication.

Description:

The aim of the study is to determine surrogate markers for prognostication of unfavorable outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. These patients are comatose. Conscious patients are unsuitable for prognostication.

This will be a prospective mono-center survey (Department of Intensive Care Medicine, University Hospital Bern), evaluating the survival and neurological outcome after cardiac arrest. The study will be performed in cooperation with the Department of Neurology and Neuroradiology, University Hospital Bern.

Inclusion: all patients surviving resuscitation after cardiac arrest older than 18 years. Detailed medical and neurological examination including 6-lead continuous EEG, 10/20 EEG and somatosensory evoked potentials, standard blood tests including Neuron-specific Enolase (NSE) and cerebral MRI will be assessed during the first 72 hours after cardiac arrest. Structured telephone interviews to determine outcome parameters (Cerebral Performance Category CPC, modified Ranking Scale mRS) will take place at day 30, after 3 and 12 month.

The results of the registry could identify early comatose patients after cardiac arrest with no chance of a good neurological recovery and regain consciousness to avoid unjustified expectations of relatives and prolonged life-sustaining therapies. A good neurological recovery is defined as a CPC of 1 and 2 or a mRS 0-2. An unfavourable neurological outcome will be defined as persistent vegetative state and death (CPC 4 and 5, mRS 5-6).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age at least 18 years

• Down time = 20 minutes (down time = time breakdown to start of professional resuscitation)

• Persistent stable circulation without further need of CPR

• Glasgow Coma Scale < 8 after return of spontaneous circulation

Exclusion Criteria:

• Cardiac arrest due to neurological causes (stroke, intracerebral hemorrhage, subarachnoid hemorrhage, SUDEP - sudden unexpected death in epilepsy)

• Cardiac arrest due to unobserved asystole

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Locations

Country	Name	City	State
Switzerland	Department of Intensive Care Medicine University Hospital Bern (Inselspital)	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Matthias Haenggi

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of survival	incidence of patients still alive 30 days after cardiac arrest or patients discharged alive from hospital	30 days after CPR
Secondary	incidence of unfavorable outcome after cardiac arrest according to Cerebral Performance Categories Scale	incidence of death within the first 72 hours after cardiac arrest and of death or unfavorable outcome according to the Cerebral Performance Categories Scales 4 and 5 (CPC 4 - Coma or vegetative state: any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness, CPC 5 - Brain death)	72 hours after CPR
Secondary	Number of Patient with a low voltage EEG, defined as amplitude below 20 microvolt more than 24 to 72 hours after resuscitation.		up to 72 hours after CPR
Secondary	Number of patients with a Cut-off Value of Neuron specific enolase >/= 33 ug/l 72 hours after resuscitation		72 hours after CPR
Secondary	Number of patient with a burst suppression EEG more than 24 to 72 hours after resuscitation		up to 72 hours after CPR
Secondary	Number of patients with an isoelectric EEG more than 24 to 72 hours after resuscitation		up to 72 hours after CPR