Mild Hypothermia for COVID-19 ARDS

COVID19 ARDS Clinical Trial

Official title:

Application of Mild Hypothermia for COVID-19 Acute Respiratory Distress

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04570462
• Other study ID #: Protocol 5.18.2020 Approved
• Status: Withdrawn
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2020
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID19 ARDS
• Hypothermia

Intervention

Other:
• Hypothermia Via Cooling Machine- Arctic Sun 5000
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.

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in metabolic requirement during and after hypothermia	indirect calorimeter measurements (Kcal/day)	Every 12 hours through study completion an average of 4 days
Secondary	Changes in oxygen requirements and levels during and after hypothermia	ABG, PaO2 (mmHg)	Every 12 hours through study completion, an average of 4 days
Secondary	length of intubation	number of hours intubated	through study completion, an average of 4 days
Secondary	Changes in carbon dioxide levels during and after hypothermia	measured by ABG, PaCO2 mmHg	Every 12 hours through study completion an average of 4 days
Secondary	does application of hypothermia reduce pro inflammatory response	ESR (mm/hr)	through study completion an average of 4 days
Secondary	does application of hypothermia reduce pro inflammatory response	Ferritin (ng/ml)	through study completion an average of 4 days
Secondary	does application of hypothermia reduce pro inflammatory response	D Dimer (ng/ml)	through study completion an average of 4 days