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When Cooling a Patient After Cardiac Arrest, Does Use of a Neuromuscular Blocking Agent Make Your Job Easier?

Information source: Lawson Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postcardiac Arrest Therapeutic Hypothermia

Intervention: Cisatracurium infusion (Drug); Cisatracurium prn bolus (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Lawson Health Research Institute

Official(s) and/or principal investigator(s):
Eyad Althenayan, MD, Principal Investigator, Affiliation: University of Western Ontario, Canada
Philip Jones, MD, FRCPC, Study Director, Affiliation: University of Western Ontario, Canada
Bryan Young, MD, FRCPC, Study Chair, Affiliation: University of Western Ontario, Canada
Ahmed F Hegazy, MD, FRCPC, Study Director, Affiliation: University of Western Ontario, Canada
Ana Igric, MD, FRCSC, Study Director, Affiliation: University of Western Ontario, Canada
Carolyn Benson, MD, Study Director, Affiliation: University of Western Ontario, Canada

Overall contact:
Ahmed F Hegazy, MD, FRCPC, Phone: 1(519) 860-4917, Email: ahmed.hegazy@londonhospitals.ca

Summary

After successful resuscitation from cardiac arrest, cooling the whole body is a well established treatment that improves the chances of the brain recovering. This however, has to be done within a certain time-frame from the arrest. The purpose of this study is to explore the best way of dosing the muscle relaxing medications that are given during the cooling process. Hypothesis: In the context of our institutional therapeutic hypothermia protocol, cisatracurium infusions lead to faster drops in core temperature when compared to cisatracurium prn boluses alone.

Clinical Details

Official title: Post-arrest Therapeutic Hypothermia. Does Use of Neuromuscular Blockers Achieve Faster Cooling Time?

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: Time to attaining target temperature (hours).

Secondary outcome:

Cerebral performance category score on hospital discharge.

Hospital length of stay postcardiac arrest (days).

Intensive care unit length of stay postcardiac arrest (days).

Detailed description: STUDY RATIONALE: A large proportion of comatose survivors of cardiac arrest presenting to our intensive care units at London Health Sciences Centre (LHSC) undergo therapeutic hypothermia. Current evidence suggests that timely achievement of target temperatures is desirable to improve outcomes. At LHSC, this intervention is protocolized with a defined set of preprinted orders that includes a dosing regimen for neuromuscular blocking agents (NMBA's). Our preprinted protocol has been in place since January of 2004. Cisatracurium infusions were part of the therapeutic hypothermia protocol until October 2011. Since that time, our protocol has changed to cisatracurium prn boluses for any observed shivering. In this study we will examine if there has been any change in the times to achieving target temperatures with the implementation of this change. It is important to note that no other change in our protocol has taken place since it was first implemented, making our before and after comparison valid and fair. Our hypothesis is that NMBA infusions lead to a faster drop in core temperatures when compared to NMBA prn boluses. If this were to stand true, we would expect cisatracurium IV infusions to result in faster reductions in core temperature when compared with cisatracurium prn boluses in the context of our therapeutic hypothermia protocol. Hypothermia has been known to cause a subclinical increase in muscle tone. This previously reported phenomenon has been named "microshivering". When attempting to reduce core temperatures, microshivering is likely a natural body response to try to restore body temperature back to normal. We therefore hypothesize that NMBA infusions are likely more effective at abolishing microshivering, which would be a desirable effect when trying to induce therapeutic hypothermia. Although current American Heart Association (AHA) guidelines suggest considering the administration of NMBA's to facilitate induced hypothermia and control shivering. Their recommendation is to minimize the duration of NMBA use or if possible, avoid them altogether. After the publication of these guidelines our institutional protocol changed to prn boluses instead of the previous infusion orders. We therefore believe it is important to examine the effects of this change on our cooling protocol and potentially add to the growing body of knowledge in this field.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Admission to adult ICU (age ≥18 years) at London Health Sciences Centre

- Primary reason for ICU admission: postcardiac arrest

- Both in-hospital and out-of-hospital cardiac arrest will be included

- ICU admission between Jan 2008 and Dec 2012.

Exclusion Criteria:

- ICU admissions primarily for reasons other than cardiac arrest.

Locations and Contacts

Ahmed F Hegazy, MD, FRCPC, Phone: 1(519) 860-4917, Email: ahmed.hegazy@londonhospitals.ca

University Hospital, London Health Sciences Centre, University of Western Ontario, London, Ontario N6A 5A5, Canada; Not yet recruiting
Ahmed F Hegazy, MD, FRCPC, Phone: 1(519) 860-4917, Email: ahmed.hegazy@londonhospitals.ca
Eyad Althenayan, MD, Phone: 1 (519) 685-8500, Ext: 19119, Email: eyad.althenayan@lhsc.on.ca
Ahmed F Hegazy, MD, FRCPC, Sub-Investigator

Victoria Hospital, London Health Sciences Centre, University of Western Ontario, London, Ontario N6A 5W9, Canada; Not yet recruiting
Ahmed F Hegazy, MD, FRCPC, Phone: 1(519) 860-4917, Email: ahmed.hegazy@londonhospitals.ca
Eyad Althenayan, MD, Phone: 1 (519) 685-8500, Ext: 19119, Email: eyad.althenayan@lhsc.on.ca
Ahmed F Hegazy, MD, FRCPC, Sub-Investigator

Additional Information

Related publications:

Sendelbach S, Hearst MO, Johnson PJ, Unger BT, Mooney MR. Effects of variation in temperature management on cerebral performance category scores in patients who received therapeutic hypothermia post cardiac arrest. Resuscitation. 2012 Jul;83(7):829-34. doi: 10.1016/j.resuscitation.2011.12.026. Epub 2012 Jan 8.

Werlhof V, Sessler DI. Pancuronium does not decrease oxygen consumption during hypothermic or normothermic cardiopulmonary bypass. Anesth Analg. 1995 Sep;81(3):465-8.

Peberdy MA, Callaway CW, Neumar RW, Geocadin RG, Zimmerman JL, Donnino M, Gabrielli A, Silvers SM, Zaritsky AL, Merchant R, Vanden Hoek TL, Kronick SL; American Heart Association. Part 9: post-cardiac arrest care: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S768-86. doi: 10.1161/CIRCULATIONAHA.110.971002. Review. Erratum in: Circulation. 2011 Feb 15;123(6):e237. Circulation. 2011 Oct 11;124(15):e403.

Starting date: January 2014
Last updated: January 9, 2014

Page last updated: August 23, 2015

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