Resuscitation Registry - Surrogate Markers of Outcome After Cardiac Arrest (CPR)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

• Study Contact: Name: Anja Weck, MD; Phone Number: +41-31-6322111; Email: anja.weck@insel.ch
• Study Contact Backup: Name: Matthias Hänggi, MD; Phone Number: +41-31-6323029; Email: matthias.haenggi@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of Intensive Care Medicine University Hospital Bern (Inselspital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with in or out of hospital cardiac arrest and a Glasgow Coma Scale below 8 after emergency service arrived who fulfill the inclusion criteria and none of the exclusion criteria will be included in the prospective registry.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of survival	incidence of patients still alive 30 days after cardiac arrest or patients discharged alive from hospital	30 days after CPR

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of patients with a Cut-off Value of Neuron specific enolase >/= 33 ug/l 72 hours after resuscitation		72 hours after CPR
Number of patient with a burst suppression EEG more than 24 to 72 hours after resuscitation		up to 72 hours after CPR
Number of patients with an isoelectric EEG more than 24 to 72 hours after resuscitation		up to 72 hours after CPR

Collaborators and Investigators

• Sponsor: Matthias Haenggi
• Investigators: Study Chair: Jukka Takala, MD, PhD, Director Department of Intensive Care Medicine University Hospital Bern (Inselspital)

Publications and helpful links

General Publications

• Kagi E, Weck A, Iten M, Levis A, Haenggi M. Value of the TTM risk score for early prognostication of comatose patients after out-of-hospital cardiac arrest in a Swiss university hospital. Swiss Med Wkly. 2020 Sep 9;150:w20344. doi: 10.4414/smw.2020.20344. eCollection 2020 Sep 7.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: KEK BE 116/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO