Abstract 115: Target Temperature Management After Out-of-Hospital Cardiac Arrest
Introduction: Previous studies may suggest an improvement in mortality and neurological function with induced hypothermia after out-of-hospital cardiac arrest (OHCA) but the overall evidence level is of a low quality and the optimal target temperature is not known.
Objectives: To evaluate differences in efficacy and safety with two strict sub-febrile target temperature management strategies after OHCA of presumed cardiac cause.
Methods: Intervention: Patients will be randomly allocated to 24 hours of temperature control at 33°C or 36°C. Temperature control will be delivered with temperature management equipment at the discretion of the trial sites.
Design: Sample size: 850 OHCA patients. Inclusion criteria: Age ≥18 years, OHCA of presumed cardiac cause, sustained return of spontaneous circulation (ROSC), unconsciousness (Glasgow Coma Score <8) after sustained ROSC. Exclusion criteria: Pregnancy, bleeding diathesis, suspected or confirmed acute intracranial bleeding or stroke, unwitnessed asystole, temperature on admission <30°C, persistent cardiogenic shock, limitations in therapy, disease making 180 day survival unlikely, pre-arrest cerebral performance (CPC) category 3 or 4. Primary outcome: All-cause mortality at maximal follow-up (min 180 days). Secondary outcomes: Composite outcome of all-cause mortality and poor neurological function (Cerebral Performance Category (CPC) 3 and 4) at hospital discharge and at 180 days. Cognitive status and quality of life at 180 days measured with modified Rankin scale, IQCODE, Mini mental state exam and SF36. Bleeding, pneumonia, sepsis, electrolyte and metabolic disorders, arrhythmia and renal replacement therapy will be recorded as potential adverse events. A biobank for prognostic biomarkers will be created.
Results: The trial has of May 2011 recruited 81 patients.
Conclusion: The TTM-trial will broaden the base for a well-founded judgement of the efficacy of temperature management after OHCA in a representative population reflecting current clinical practice, investigating two sub-febrile temperatures. NCT01020916
- © 2011 by American Heart Association, Inc.