In-hospital Cardiac Arrest - Dynamics and State Transitions

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Norwegian Air Ambulance Foundation
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00920244
First received: June 12, 2009
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to analyse transitions in cardiac rhythm and hemodynamic variables during resuscitation of patients with in-hospital cardiac arrest.


Condition Intervention
Heart Arrest
Death, Sudden, Cardiac
Procedure: Cardiopulmonary resuscitation (CPR)
Drug: Epinephrine
Drug: Atropine
Drug: Amiodarone
Device: External defibrillator

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamics and State Transitions During Resuscitation in In-hospital Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Survival to discharge [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short-term survival [ Time Frame: minutes-days ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Study Completion Date: June 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Cardiopulmonary resuscitation (CPR)
    CPR is performed according to international and national guidelines on all patients.
    Other Name: CPR
    Drug: Epinephrine
    According to guidelines epinephrine 1 mg i.v. is administered every 3 minutes during cardiopulmonary resuscitation.
    Other Name: Adrenaline
    Drug: Atropine
    According to CPR guidelines atropine 3 mg i.v. is administered if asystole og PEA with frequency < 60 beat/min.
    Drug: Amiodarone
    According to guidelines amiodarone 300 mg i.v. is administered if recurrent ventricular fibrillation/tachycardia (VF/VT) during CPR.
    Other Name: Cordarone
    Device: External defibrillator
    According to CPR guidelines patients with shockable rhythms may receive DC shocks. The defibrillator also stores physiological information regarding cardiac rhythm, pulse-oximetry, and end-tidal CO2 from endotracheal tube.
    Other Name: Defibrillator
Detailed Description:

In-hospital cardiac arrest carries a grave prognosis, with survival to discharge in the range of 15-20%. Key factors determining outcome include the presenting cardiac rhythm, aetiology, and early initiation of resuscitation. Some cardiac rhythms benefit from defibrillation (shockable rhythms). During resuscitation patients may switch between shockable and non-shockable rhythms, and may show signs of spontaneous circulation temporarily. Depending on rhythm and according to guidelines, patients receive DC shocks (defibrillator) and/or i.v. adrenaline, atropine and amiodarone, which may affect state-transitions. We wish to make statistical analysis (time-series analysis, Markov modelling) of these state-transitions and variations in hemodynamic variables during resuscitation, related to CPR interventions and the cause of arrest. The cause of arrest will be determined based on chart records, interview with staff and autopsy if appropriate. One hypothesis is that differences in the patterns of state-transitions may reflect underlying aetiology, which may guide in future decision-making during resuscitation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with in-hospital cardiac arrest at St.Olavs Hospital (Trondheim, Norway) during the study period.

Criteria

Inclusion Criteria:

  • Patients with in-hospital cardiac arrest who are resuscitated

Exclusion Criteria:

  • Younger than 18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920244

Locations
Norway
St.Olavs Hospital, Department of Anesthesia
Trondheim, Norway, 7014
Sponsors and Collaborators
St. Olavs Hospital
Norwegian Air Ambulance Foundation
Norwegian University of Science and Technology
Investigators
Study Chair: Eirik Skogvoll, MD, PhD St. Olavs Hospital
Principal Investigator: Trond Nordseth, MD St. Olavs Hospital
  More Information

Publications:
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00920244     History of Changes
Other Study ID Numbers: 4.2008.2402 (REK), 08/11457, 20708/2/IB
Study First Received: June 12, 2009
Last Updated: October 8, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by St. Olavs Hospital:
Resuscitation
Cardiac arrest
State-transitions
Markov

Additional relevant MeSH terms:
Death, Sudden
Heart Arrest
Death, Sudden, Cardiac
Death
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Epinephrine
Atropine
Epinephryl borate
Amiodarone
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on July 23, 2014