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- Title
2016 - Therapeutic hypothermia during CPR did not improve survival to discharge in out-of-hospital cardiac arrest.
- Authors
Hunter, Benton R.
- Abstract
Question In patients with out-of-hospital cardiac arrest (OHCA), does inducing therapeutic hypothermia (TH) during cardiopulmonary resuscitation improve survival compared with usual care? Methods Design Randomized controlled trial (RCT) (Rapid Infusion of Cold Normal Saline [RINSE] trial). ClinicalTrials.gov NCT01173393. Allocation Unclear allocation concealment.* Blinding Blinded* (data analysts). Follow-up period Up to hospital discharge. Setting 3 cities in Australia. Patients 1202 adults > 18 years of age (mean age 65 y, 74% men) who had spontaneous OHCA and were in cardiac arrest on arrival of emergency medical services, had IV access established, and remained in cardiac arrest after initial resuscitation treatments (defibrillation, IV cannulation, epinephrine administration, and ventilation with 100% oxygen). Exclusion criteria included OHCA due to trauma, suspected intracranial bleeding, hypothermia (< 34.5 °C), inpatient status, pregnancy, or known nonresuscitation directives. Intervention Cooling with rapid infusion of cold saline, 30 mL/kg up to 2 L by peripheral IV cannula (TH) (n = 618), or continuation of usual care (n = 580). Outcomes Survival to hospital discharge. Secondary outcomes included death at the scene, transport with return of spontaneous circulation (ROSC), discharge to home, and adverse events. 1206 patients with initial shockable rhythms were needed to detect a 7% absolute increase in overall survival, assuming a 20% survival rate in the usual care group (80% power, α = 0.05); 2512 patients were planned to be enrolled. Patient follow-up > 99.5% of eligible patients (90% of 1324 randomized patients) (intention-to-treat analysis). Main results Enrollment was stopped early because hospitals changed their temperature management in post-cardiac arrest patients due to results from another RCT (see Commentary). Compared with usual care, TH reduced the likelihood of ROSC at the scene and increased risk for acute pulmonary edema; groups did not differ for survival to hospital discharge, discharge to home, or death at the scene (Table). Conclusion In patients with out-of-hospital cardiac arrest, therapeutic hypothermia during cardiopulmonary resuscitation did not improve survival to discharge more than usual care.
- Subjects
AUSTRALIA; THERAPEUTICS; CARDIAC arrest; CONFIDENCE intervals; CARDIOPULMONARY resuscitation; EMERGENCY medical services; EMERGENCY medicine; INDUCED hypothermia; INTRAVENOUS therapy; PATIENTS; PHYSIOLOGIC salines; PULMONARY edema; SURVIVAL analysis (Biometry); RANDOMIZED controlled trials; DISCHARGE planning; RELATIVE medical risk; TREATMENT effectiveness; DESCRIPTIVE statistics
- Publication
ACP Journal Club, 2016, Vol 165, Issue 12, p1
- ISSN
1056-8751
- Publication type
Article