STUDY OBJECTIVE: Studies have suggested that inducing mild hypothermia improves neurologic outcomes after traumatic brain injury, major stroke, traumatic hemorrhage, and cardiac arrest. Although infusion of cold normal saline solution is a simple and inexpensive method for initiating hypothermia, human cold-defense mechanisms potentially make this route stressful or ineffective. We hypothesize that rapid infusion of 30 mL/kg of cold (4 degrees C, 39.2 degrees F) 0.9% saline solution during 30 minutes to healthy subjects (aged 27 [standard deviation (SD) 4] years) will reduce core body temperature to the therapeutic range of 33 degrees C to 35 degrees C (91.4 degrees F to 95 degrees F). METHODS:Sixteen subjects were randomly assigned to receive either cold (4 degrees C, 39.2 degrees F) or room temperature (23 degrees C, 73.4 degrees F) normal saline solution. Subjects were not informed of their assignment, but blinding was not possible after initiation of the infusion. Core temperature, skin temperature, and vital signs were recorded every 2 minutes. Subjects indicated global discomfort during the infusion on a 100-mm visual analog scale at 5-minute intervals. RESULTS:Core temperature decreased in both the cold saline solution (1.0 degrees C [SD 0.4 degrees C]/1.8 degrees F [0.7 degrees F]) and room temperature saline solution (0.5 degrees C [SD 0.1 degrees C]/0.9 degrees F [0.2 degrees F]) groups, whereas skin temperature was unchanged. Slopes calculated from the core temperature cooling curves indicate that the majority of cooling occurred during the first half of the infusion. Examination of the core temperature cooling curves revealed a 2-phase temporal pattern in 30-minute cooling curves. The early phase, spanning 0 to 14 minutes, demonstrated rapid cooling in both groups, with a larger effect observed in subjects receiving cold saline solution. CONCLUSION: In this pilot study of healthy volunteers, rapid administration of cold saline solution to awake normothermic volunteers resulted in 1 degrees C (1.8 degrees F) cooling but did not induce a therapeutic plane of hypothermia. This change in core temperature was not accompanied by significant changes in skin temperature. These data suggest that a reduction in core temperature of about 1 degrees C (1.8 degrees F) can be achieved in healthy humans before a thermoregulatory response is triggered and that rapid infusion of cold intravenous fluids is insufficient by itself to overcome this response. The clinically relevant control arm of room temperature saline solution also resulted in mild core cooling.
RCT Entities:
STUDY OBJECTIVE: Studies have suggested that inducing mild hypothermia improves neurologic outcomes after traumatic brain injury, major stroke, traumatic hemorrhage, and cardiac arrest. Although infusion of cold normal saline solution is a simple and inexpensive method for initiating hypothermia, human cold-defense mechanisms potentially make this route stressful or ineffective. We hypothesize that rapid infusion of 30 mL/kg of cold (4 degrees C, 39.2 degrees F) 0.9% saline solution during 30 minutes to healthy subjects (aged 27 [standard deviation (SD) 4] years) will reduce core body temperature to the therapeutic range of 33 degrees C to 35 degrees C (91.4 degrees F to 95 degrees F). METHODS: Sixteen subjects were randomly assigned to receive either cold (4 degrees C, 39.2 degrees F) or room temperature (23 degrees C, 73.4 degrees F) normal saline solution. Subjects were not informed of their assignment, but blinding was not possible after initiation of the infusion. Core temperature, skin temperature, and vital signs were recorded every 2 minutes. Subjects indicated global discomfort during the infusion on a 100-mm visual analog scale at 5-minute intervals. RESULTS: Core temperature decreased in both the cold saline solution (1.0 degrees C [SD 0.4 degrees C]/1.8 degrees F [0.7 degrees F]) and room temperature saline solution (0.5 degrees C [SD 0.1 degrees C]/0.9 degrees F [0.2 degrees F]) groups, whereas skin temperature was unchanged. Slopes calculated from the core temperature cooling curves indicate that the majority of cooling occurred during the first half of the infusion. Examination of the core temperature cooling curves revealed a 2-phase temporal pattern in 30-minute cooling curves. The early phase, spanning 0 to 14 minutes, demonstrated rapid cooling in both groups, with a larger effect observed in subjects receiving cold saline solution. CONCLUSION: In this pilot study of healthy volunteers, rapid administration of cold saline solution to awake normothermic volunteers resulted in 1 degrees C (1.8 degrees F) cooling but did not induce a therapeutic plane of hypothermia. This change in core temperature was not accompanied by significant changes in skin temperature. These data suggest that a reduction in core temperature of about 1 degrees C (1.8 degrees F) can be achieved in healthy humans before a thermoregulatory response is triggered and that rapid infusion of cold intravenous fluids is insufficient by itself to overcome this response. The clinically relevant control arm of room temperature saline solution also resulted in mild core cooling.
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Authors: Clifton W Callaway; Jonathan Elmer; Francis X Guyette; Bradley J Molyneaux; Kacey B Anderson; Philip E Empey; Stacy J Gerstel; Kate Holquist; Melissa J Repine; Jon C Rittenberger Journal: PLoS One Date: 2015-08-03 Impact factor: 3.240