Trial Outcomes & Findings for Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest (NCT NCT00391469)

NCT ID: NCT00391469

Last Updated: 2014-12-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 1359 participants
• Primary outcome timeframe: at hospital discharge
• Results posted on: 2014-12-02

Participant Flow

Participant milestones

Measure	Intervention Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest. Rapid infusion of cold normal saline	Control standard of care
Overall Study STARTED	688	671
Overall Study COMPLETED	688	671
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest

Baseline characteristics by cohort

Measure	VF-randomized to Standard Treatment n=291 Participants standard treatment following VF cardiac arrest	VF-randomized to Hypothermia n=292 Participants Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest. Rapid infusion of cold normal saline	Non-VF Randomized to Standard Treatment n=380 Participants standard treatment following non-VF cardiac arrest	Non-VF-randomized to Hypothermia n=396 Participants Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest. Rapid infusion of cold normal saline	Total n=1359 Participants Total of all reporting groups
Age, Continuous	62.1 years STANDARD_DEVIATION 15.6 • n=5 Participants	62.1 years STANDARD_DEVIATION 14.2 • n=7 Participants	67.5 years STANDARD_DEVIATION 16.5 • n=5 Participants	68.3 years STANDARD_DEVIATION 16.3 • n=4 Participants	65.1 years STANDARD_DEVIATION 15.3 • n=21 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	65 Participants n=7 Participants	175 Participants n=5 Participants	180 Participants n=4 Participants	494 Participants n=21 Participants
Sex: Female, Male Male	217 Participants n=5 Participants	227 Participants n=7 Participants	205 Participants n=5 Participants	216 Participants n=4 Participants	865 Participants n=21 Participants
Region of Enrollment United States	291 participants n=5 Participants	292 participants n=7 Participants	380 participants n=5 Participants	396 participants n=4 Participants	1359 participants n=21 Participants

PRIMARY outcome

Timeframe: at hospital discharge

Outcome measures

Measure	VF-randomized to Standard Treatment n=291 Participants standard treatment following VF cardiac arrest	VF-randomized to Hypothermia n=292 Participants Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest. Rapid infusion of cold normal saline	Non-VF Randomized to Standard Treatment n=380 Participants standard treatment following non-VF cardiac arrest	Non-VF-randomized to Hypothermia n=396 Participants Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest. Rapid infusion of cold normal saline
Number Alive at Hospital Discharge	187 participants	183 participants	62 participants	76 participants

SECONDARY outcome

Timeframe: at time of discharge

Outcome measures

Measure	VF-randomized to Standard Treatment n=291 Participants standard treatment following VF cardiac arrest	VF-randomized to Hypothermia n=292 Participants Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest. Rapid infusion of cold normal saline	Non-VF Randomized to Standard Treatment n=380 Participants standard treatment following non-VF cardiac arrest	Non-VF-randomized to Hypothermia n=396 Participants Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest. Rapid infusion of cold normal saline
Neurologic Status at Discharge-full Recovery	145 participants	125 participants	34 participants	36 participants

Adverse Events

Intervention-hypo

Serious events: 547 serious events

Other events: 0 other events

Deaths: 0 deaths

Control-standard Care

Serious events: 513 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention-hypo n=688 participants at risk Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest. Rapid infusion of cold normal saline	Control-standard Care n=671 participants at risk standard care
Cardiac disorders Re-arrest postrandomization	25.7% 176/686	20.6% 138/671
Cardiac disorders Use of pressers post randomization	9.0% 62/686	8.8% 59/671
Cardiac disorders prehospital deaths	1.3% 9/688	1.6% 11/671
Cardiac disorders death in emergency dept.	12.8% 88/688	12.7% 85/671
Cardiac disorders use of diuretics first 12 h	17.7% 119/674	12.5% 81/648
Cardiac disorders pulmonary edema on first chest X-ray	40.6% 256/631	30.2% 184/609

Other adverse events

Adverse event data not reported

Additional Information

Francis Kim, MD Associate Professor of Medicine

University of Washington

Phone: 206-744-8712

Email: fkim@u.washington.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place