Resuscitation Registry - Surrogate Markers of Outcome After Cardiac Arrest

NCT02722460 | Completed

• 1 other identifier: KEK BE 116/15
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• incidence of survival

  incidence of patients still alive 30 days after cardiac arrest or patients discharged alive from hospital

  30 days after CPR

Secondary Outcomes (5)

• incidence of unfavorable outcome after cardiac arrest according to Cerebral Performance Categories Scale

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Matthias Haenggi: lead

Study Sites (1)

Department of Intensive Care Medicine University Hospital Bern (Inselspital)

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32920792 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jukka Takala, MD, PhD

  Director Department of Intensive Care Medicine University Hospital Bern (Inselspital)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician, Departement of Intensive Care Medicine

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 30, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)