Mild Hypothermia for COVID-19 ARDS

Application of Mild Hypothermia for COVID-19 Acute Respiratory Distress

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID19 ARDS
• Intervention / Treatment: Other: Hypothermia Via Cooling Machine- Arctic Sun 5000

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental Arm- Induction of Mild Hypothermia Protocol; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in oxygen requirements and levels during and after hypothermia	ABG, PaO2 (mmHg)	Every 12 hours through study completion, an average of 4 days
length of intubation	number of hours intubated	through study completion, an average of 4 days
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
does application of hypothermia reduce pro inflammatory response	ESR (mm/hr)	through study completion an average of 4 days
does application of hypothermia reduce pro inflammatory response	Ferritin (ng/ml)	through study completion an average of 4 days
does application of hypothermia reduce pro inflammatory response	D Dimer (ng/ml)	through study completion an average of 4 days

Collaborators and Investigators

• Sponsor: Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Body Temperature Changes; COVID-19; Hypothermia
• Other Study ID Numbers: Protocol 5.18.2020 Approved

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No