Clinical trial NCT04570462: Mild Hypothermia for COVID-19 ARDS
Official title: Application of Mild Hypothermia for COVID-19 Acute Respiratory Distress
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID19 ARDS
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form from Legally Authorized Representative.
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 years or above
4. COVID positive
5. On mechanical ventilation with either: refractory respiratory acidosis (ph ≤ 7.20), hypercarbia (pCO2 ≥ 55 mmHg), refractory hypoxia (pO2/FIO2 \<150), or plateau pressures \>30

Exclusion Criteria:

1. Bleeding (active bleeding, platelets less than 50,000)
2. Uncontrolled cardiac arrhythmia
3. History of cryoglobulinemia, major trauma, pregnancy
4. Active non-COVID-19 infection that is not controlled with antibiotic or antifungal regimen

Primary outcomes:
measure: Changes in metabolic requirement during and after hypothermia
timeFrame: Every 12 hours through study completion an average of 4 days
Secondary outcomes:
measure: Changes in oxygen requirements and levels during and after hypothermia
timeFrame: Every 12 hours through study completion, an average of 4 days
measure: length of intubation
timeFrame: through study completion, an average of 4 days
measure: Changes in carbon dioxide levels during and after hypothermia
timeFrame: Every 12 hours through study completion an average of 4 days
measure: does application of hypothermia reduce pro inflammatory response
timeFrame: through study completion an average of 4 days
measure: does application of hypothermia reduce pro inflammatory response
timeFrame: through study completion an average of 4 days
measure: does application of hypothermia reduce pro inflammatory response
timeFrame: through study completion an average of 4 days
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
References: