Some patients with COVID have abnormally high carbon dioxide and low oxygen levels despite being on the ventilator. The hypothesis of the study is that the application of mild hypothermia to patients with COVID will decrease their metabolic rate and improve their oxygenation and carbon dioxide levels.
A significant contributor to the morbidity and mortality from COVID-19 is from the abnormal carbon dioxide and oxygen levels in COVID-19 patients. Metabolic studies done on COVID-19 patients have shown that these patients have abnormally high metabolic rates. High metabolic rates results in increased carbon dioxide production and increased oxygen usage, both of which can result in high carbon dioxide and low oxygen levels. As some patients with severe COVID-19 continue to have high carbon dioxide levels and/or low oxygen levels despite being on the ventilator, it is hypothesized that decreasing the metabolic rate in these COVID-19 patients will help their oxygen and carbon dioxide levels. Mild hypothermia is currently used in comatose survivors of cardiac arrest to improve mortality and neurological outcomes. Mild hypothermia is also an effective way to reduce metabolic demand. The aim is to apply mild hypothermia to COVID-19 patients to decrease metabolic rate in order to improve their oxygen and carbon dioxide levels. Although the application for mild hypothermia has been widely adopted in some patient populations, it has never been applied in COVID-19 patients. If we can develop a strategy to help improve the oxygen and carbon dioxide levels in COVID-19 patients, it may lead to improvements in their overall outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Initiate hypothermia using the Arctic Sun.The Arctic Sun 5000® is set to a temperature of 34.5 C to lower the body temperature. Duration of hypothermia will be 48 hours after which the subject will be rewarmed. Metabolic rate, or indirect Calorimetry, will be assessed at baseline, day 1 of hypothermia, day 2 of hypothermia before rewarming, and after full rewarming. CBC, basic metabolic profile, magnesium, phosphorus, coagulation profile, ABG, inflammatory markers would be drawn every 12 hours during hypothermia until subject has achieved full rewarming and once after full rewarming. The entire hypothermia procedure will last 48 hours. Acceptable rewarming range is a temperature of 36.5C to 37.5C. The subject body temperature rewarming is typically set over 6-8 hours. Therefore, the final 6-8 hours of the 48 hour time period is set to rewarm the subject.
North Shore University Hospital
Manhasset, New York, United States
Changes in metabolic requirement during and after hypothermia
indirect calorimeter measurements (Kcal/day)
Time frame: Every 12 hours through study completion an average of 4 days
Changes in oxygen requirements and levels during and after hypothermia
ABG, PaO2 (mmHg)
Time frame: Every 12 hours through study completion, an average of 4 days
length of intubation
number of hours intubated
Time frame: through study completion, an average of 4 days
Changes in carbon dioxide levels during and after hypothermia
measured by ABG, PaCO2 mmHg
Time frame: Every 12 hours through study completion an average of 4 days
does application of hypothermia reduce pro inflammatory response
ESR (mm/hr)
Time frame: through study completion an average of 4 days
does application of hypothermia reduce pro inflammatory response
Ferritin (ng/ml)
Time frame: through study completion an average of 4 days
does application of hypothermia reduce pro inflammatory response
D Dimer (ng/ml)
Time frame: through study completion an average of 4 days
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