Journal of Neurocritical Care (Jun 2016)
Targeted Temperature Management at 36°C after In-Hospital Cardiac Arrest Trial (TTM-36 IHCA Trial): Study Protocol for an Investigator-Initiated, Single-Center, Randomized, Controlled, Assessor-Blinded, Pilot Clinical Trial
Abstract
Background: Targeted temperature management (TTM) has neuroprotective effects in comatose patients despite restoration of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest. However, no TTM trials have been performed for in-hospital cardiac arrest (IHCA). Methods: We aim to enroll 60 comatose adults with ROSC after IHCA. Eligible patients are randomly assigned in a 2:1 ratio to either the intervention group or the control group with stratification according to the electrocardiography rhythm. Core body temperature is maintained at 36 °C for the initial 72 hours (TTM-36) in the intervention group. Fever control using conventional methods is attempted in the control group. The primary efficacy outcome is Cerebral Performance Category (CPC) of 3-5 at 180 days. The secondary efficacy outcomes include CPC of 3-5 at 7 days and 30 days; modified Rankin Scale of 4-6 at 7 days, 30 days, and 180 days; daily measured serum levels of neuron specific enolase for the first 5 days; predefined electroencephalography patterns suggesting poor prognosis; repeated measurements of brain MRI including diffusion-weighted imaging, fluid attenuated inversion recovery, susceptibility-weighted imaging, high resolution T1-weighted imaging, diffusion tensor imaging, and resting state functional MRI at 4 days, 30 days, and 180 days; detailed neuropsychological tests; questionnaire for depression, quality of life, activities of daily living, and neuropsychiatric symptoms; and scales for parkinsonism and ataxia. The safety outcomes include cardiac re-arrest, arrhythmia, pneumonia, septic shock, infection, bleeding, and shivering. Results: We are currently recruiting the study patients. Conclusion: The results of this trial are expected to provide evidence for feasibility, safety, and efficacy of TTM-36 in patients with IHCA.
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