In-hospital Cardiac Arrest - Dynamics and State Transitions - Full Text View

Sponsor:	St. Olavs Hospital
Collaborators:	Norwegian Air Ambulance Foundation Norwegian University of Science and Technology
Information provided by (Responsible Party):	St. Olavs Hospital
ClinicalTrials.gov Identifier:	NCT00920244

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:

MedlinePlus related topics: CPR Cardiac Arrest

Drug Information available for: Epinephrine bitartrate Epinephrine Atropine Amiodarone hydrochloride Amidox Amiodarone Atropine sulfate

U.S. FDA Resources

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
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Intervention Details:

CPR is performed according to international and national guidelines on all patients.

Other Name: CPR

According to guidelines epinephrine 1 mg i.v. is administered every 3 minutes during cardiopulmonary resuscitation.

Other Name: Adrenaline

According to CPR guidelines atropine 3 mg i.v. is administered if asystole og PEA with frequency < 60 beat/min.

According to guidelines amiodarone 300 mg i.v. is administered if recurrent ventricular fibrillation/tachycardia (VF/VT) during CPR.

Other Name: Cordarone

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

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

Contacts

Contact: Eirik Skogvoll, MD, PhD	+4772574549	eirik.skogvoll@ntnu.no
Contact: Trond Nordseth, MD	+4797066399	trond.nordseth@ntnu.no

Locations

Norway
St.Olavs Hospital, Department of Anesthesia	Recruiting
Trondheim, Norway, 7014
Principal Investigator: Trond Nordseth, MD
Sub-Investigator: Daniel Bergum, MD

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:

Skogvoll E, Nordseth T. The early minutes of in-hospital cardiac arrest: Shock or CPR? A population based prospective study. Scand J Trauma Resusc Emerg Med. 2008 Sep 22;16(1):11.

Skogvoll E, Eftestøl T, Gundersen K, Kvaløy JT, Kramer-Johansen J, Olasveengen TM, Steen PA. Dynamics and state transitions during resuscitation in out-of-hospital cardiac arrest. Resuscitation. 2008 Jul;78(1):30-7. Epub 2008 Apr 10.

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:	November 3, 2011
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs

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
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
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012