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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00920244
Other study ID # 4.2008.2402 (REK)
Secondary ID 08/1145720708/2/
Status Completed
Phase
First received
Last updated
Start date August 2009
Est. completion date April 2015

Study information

Verified date August 2018
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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 direct current (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.


Recruitment information / eligibility

Status Completed
Enrollment 285
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with in-hospital cardiac arrest who are resuscitated

Exclusion Criteria:

- Younger than 18 years old

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cardiopulmonary resuscitation (CPR)
CPR is performed according to international and national guidelines on all patients.
Drug:
Epinephrine
According to guidelines epinephrine 1 mg i.v. is administered every 3 minutes during cardiopulmonary resuscitation.
Atropine
According to CPR guidelines atropine 3 mg i.v. is administered if asystole og PEA with frequency < 60 beat/min.
Amiodarone
According to guidelines amiodarone 300 mg i.v. is administered if recurrent ventricular fibrillation/tachycardia (VF/VT) during CPR.
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 carbon dioxide (CO2) from endotracheal tube.

Locations

Country Name City State
Norway St.Olavs Hospital, Department of Anesthesia Trondheim

Sponsors (3)

Lead Sponsor Collaborator
St. Olavs Hospital Norwegian Air Ambulance Foundation, Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Skjeflo GW, Nordseth T, Loennechen JP, Bergum D, Skogvoll E. ECG changes during resuscitation of patients with initial pulseless electrical activity are associated with return of spontaneous circulation. Resuscitation. 2018 Jun;127:31-36. doi: 10.1016/j.r — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Survival to discharge 1 year
Secondary Short-term survival minutes-days
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