Mild Hypothermia for COVID-19 ARDS

Not Applicable

Withdrawn

• Conditions: COVID19 ARDS
• Interventions: Other: Hypothermia Via Cooling Machine- Arctic Sun 5000

• Registration Number: NCT04570462
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study Start: 2020-05-18
• Study First Submitted: 2020-07-21
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-09-30
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Arm- Induction of Mild Hypothermia Protocol	Hypothermia Via Cooling Machine- Arctic Sun 5000	Determination of metabolic rate by the metabolic cart (noninvasive connection of the device to the ventilator for 20 minutes). Initiate hypothermia (established Northwell hypothermia status post cardiac arrest protocol) using the Arctic Sun. The Arctic Sun 5000® is set to a temperature of 34.5 C to lower the body temperature.

Primary Outcome Measures

Name	Time	Method
Changes in metabolic requirement during and after hypothermia	Every 12 hours through study completion an average of 4 days	indirect calorimeter measurements (Kcal/day)

Secondary Outcome Measures

Name	Time	Method
Changes in oxygen requirements and levels during and after hypothermia	Every 12 hours through study completion, an average of 4 days	ABG, PaO2 (mmHg)
length of intubation	through study completion, an average of 4 days	number of hours intubated
Changes in carbon dioxide levels during and after hypothermia	Every 12 hours through study completion an average of 4 days	measured by ABG, PaCO2 mmHg
does application of hypothermia reduce pro inflammatory response	through study completion an average of 4 days	D Dimer (ng/ml)

Trial Locations

Locations (1)

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States