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Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD, Al Hallstrom PhD, Peter Kudenchuk MD, Thomas Rea MD, Michael Copass MD, David Carlbom MD Steven Deem MD, WT Longstreth Jr MD, Michele Olsufka RN, Leonard Cobb MD University of Washington Seattle, WA Randomized Clinical Trial of Pre-hospital Induction of Mild Hypothermia in Out-of-Hospital Cardiac Arrest Patients Using a Rapid Infusion of 4 o C Normal Saline

Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

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Randomized Clinical Trial of Pre-hospital Induction of Mild Hypothermia in Out-of-Hospital Cardiac Arrest Patients Using a Rapid Infusion of 4 o C Normal Saline. Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD , Al Hallstrom PhD, Peter Kudenchuk MD, Thomas Rea MD, - PowerPoint PPT Presentation

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Page 1: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD, Al Hallstrom PhD, Peter Kudenchuk MD, Thomas Rea MD,

Michael Copass MD, David Carlbom MDSteven Deem MD, WT Longstreth Jr MD, Michele Olsufka RN,

Leonard Cobb MD

University of WashingtonSeattle, WA

Randomized Clinical Trial of Pre-hospital Induction of Mild Hypothermia

in Out-of-Hospital Cardiac Arrest Patients Using a Rapid Infusion of 4oC

Normal Saline

Page 2: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Background

• Hospital cooling (32-34oC) improves neurologic outcome after out-of-hospital ventricular fibrillation (VF)

• Pre-hospital cooling may result in better outcomes compared to hospital alone

• Pre-hospital infusion of cold fluid to reduce temperature

• Determine whether prehospital cooling improves outcomes from cardiac arrest with VF or non-VF

Page 3: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Trial Setting/Design• Emergency medical services (EMS) agencies

in Seattle and surrounding King County• Individual subjects randomized to

– Intervention-Rapid infusion of 2 liters of 4oC NS after ROSC, sedation, skeletal muscle relaxation

– Control-standard care

• Randomization stratified by – Receipt of hospital cooling – First recorded rhythm

Page 4: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Eligibility

Inclusion Criteria AdultsReturn of pulseTracheal intubationIntravenous accessUnconsciousEsophageal temp probe

Exclusion CriteriaTraumatic cardiac arrestAge < 18Following commandsTemperature < 34ºC

Page 5: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Trial FlowField Cardiac Arrest

1364

N=583VF

Intervention292

Control291

5696

Eligible

Enrolled

2377

N=776Non-VF

Intervention396

Control380

Not Eligible (3319)

Not Enrolled (1013)

Outcomes: Survival at discharge/neurologic status

Page 6: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

VF NON-VFIntervention

(n=292)Control(n=291)

Intervention(n=396)

Control(n=380)

Age 62.1 62.1 68.3 67.5Men (78%) (75%) (54%) (54%)

Witnessed cardiac arrest (78%) (74%) (53%) (52%)

CPR before EMS arrival (68%) (64%) (50%) (53%)

Time from call to randomization 32.9 32.5 34.4 35.2

Time from call to first responder

arrival5.3 5.2 5.4 5.2

Time from call to sustained ROSC 25 24 28 27

Baseline Characteristics

Page 7: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Temperature Effects

VF Non-VF

Intervention Control P value Intervention Control P value

Temperature at randomization

(95% CI) oC

36.1 (36.0-36.2)

(n=292)

36.0(35.9-36.1)

(n=290)0.16

36.0 (35.9-36.1)

(n=396)

35.9 (35.8-36.0)

(n=379)0.09

Temperature at hospital

arrival, oC

35.0(34.8-35.2)(n= 260)

35.9 (35.8-36.0)

(n=212)<0.0001

34.8 (34.6-35.0)

(n=350)

35.7 (35.6-35.8)

(n=248)<0.0001

Difference in temperature

between randomization

and arrival mean oC

-1.2 (-1.33- -1.07)

(n=260)

-0.1 (-0.19- -0.02)

(n=212)<0.0001

-1.3 (-1.4 - -1.2)

(n=350)

-0.1 (-0.19 --0.01)

(n=248)<0.0001

Page 8: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Outcomes-Survival

VF intervention n=292control n=291

Non-VF intervention n=396

control n=380

Page 9: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Outcomes-neurologic status at discharge

Page 10: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Secondary Outcomes- Days to achieve awakening

VF Non-VF

Page 11: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Intervention Control P-value

Re-arrest after randomization 176 (26%) 138 (21%) 0.008

Pressors after randomization 62 (9%) 59 (9%) 0.82

Deaths in field 9 (1.3%) 11 (1.6%) 0.61Time from first

dispatch to hospital arrival

(min)

51+13 49+14 0.006

Safety- prehospital

Page 12: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Intervention Control P-value

Deaths in ED 88 (12.8%) 85 (12.7%) 0.95Pressors in the first 12 hours of

arrival374 (56%) 365 (56%) 0.93

Diuretics in the first 12 hours of

arrival119 (18%) 81 (12%) 0.009

Diuretics in 12-48 hours of arrival 151 (23%) 109 (17%) 0.011

pH 7.16+0.23 7.20+0.29 0.005

PaO2 (mmHg) 189+135 218+144 <0.0001

Pulmonary edema on 1st chest x-ray 256 (41%) 184 (30%) <0.0001

Pulmonary edemaon 2nd chest x-ray 133 (27%) 123 (26%) 0.95

Safety- ED and hospital

Page 13: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Summary of prehospital cooling

Page 14: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Conclusions

• Cold NS reduced core temperature by hospital arrival

• Use of cold NS associated with increased re-arrest during transport and increased transient pulmonary edema

• Lack of benefit of prehospital cooling consistent with previous smaller trials

• Prehospital cooling with cold NS did not improve survival or neurologic outcomes in patients with out-of-hospital VF or non-VF

Page 15: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Implications

• Prehospital cooling does not add benefit to hospital-initiated cooling

• Cold fluid has associated risks• Study findings do not support routine

initiation of hypothermia using cold fluid in the prehospital setting

Page 16: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

Paramedics in Seattle and King CountyHospitals: Harborview Medical Center, Swedish Medical Center, Virginia Mason Hospital,

UWMC, Northwest Hospital, Overlake Hospital, Valley Medical Center, Auburn General Hospital, St. Francis Hospital, Stevens Hospital.

DSMB: Chair: Kyra Becker, MD. Members: Margaret Neff, MD, Tina Chang, MD, Karl B. Kern, MD, Nancy Temkin, PhD, Ralph D’Agostino, PhD, Chief Earl Sodeman, Seattle Fire Department, Thomas Hearne, Michele Plorde, King County Public Health, Emergency Medical Services Division.

Study Nurses: Dianne K. Staloch, Karen Dong, Sue Scruggs, Alana C. Clark, Jane Edelson, Debi Solberg, Sally Ragsdale, Kathleen Fair, Barbara Ricker

Funding: NIH/NHLBI

Acknowledgements

Page 17: Francis Kim MD, Graham Nichol MD MPH, Charles Maynard PhD ,

F Kim and coauthors

Effect of Prehospital Induction of Mild Hypothermia on Survival and Neurological Status Among Adults With Cardiac Arrest: A Randomized Clinical Trial

Published online November 17, 2013

Available at www.jama.com and also at mobile.jamanetwork.com

jamanetwork.com