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:	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 Cardiopulmonary Resuscitation Death, Sudden, Cardiac	Procedure: Cardiopulmonary resuscitation (CPR) Drug: Epinephrine Drug: Atropine Drug: Amiodarone Device: External defibrillator

Study Type:	Observational
Study Design:	Cohort, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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.

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

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.

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.

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:	Foundation ( Norwegian Air Ambulance Foundation )
Study ID Numbers:	4.2008.2402 (REK), 08/11457 (SHDir), 20708/2/IB (NSD)
Study First Received:	June 12, 2009
Last Updated:	August 10, 2009
ClinicalTrials.gov Identifier:	NCT00920244 History of Changes
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

Additional relevant MeSH terms:

Parasympatholytics
Respiratory System Agents
Vasodilator Agents
Death
Neurotransmitter Agents
Cholinergic Antagonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cholinergic Agents
Adrenergic Agonists
Pathologic Processes
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases

Anti-Arrhythmia Agents
Death, Sudden, Cardiac
Epinephrine
Heart Diseases
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Sympathomimetics
Anti-Asthmatic Agents
Enzyme Inhibitors
Heart Arrest
Cardiovascular Agents
Amiodarone
Pharmacologic Actions
Muscarinic Antagonists
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on February 08, 2010