Mild Hypothermia for COVID-19 ARDS

NCT04570462 | Withdrawn DMC

• 1 other identifier: Protocol 5.18.2020 Approved
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID19 ARDS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in oxygen requirements and levels during and after hypothermia

  Every 12 hours through study completion, an average of 4 days

• length of intubation

  through study completion, an average of 4 days

• Changes in carbon dioxide levels during and after hypothermia

  Every 12 hours through study completion an average of 4 days

• does application of hypothermia reduce pro inflammatory response

  through study completion an average of 4 days

• does application of hypothermia reduce pro inflammatory response

  through study completion an average of 4 days

Study Arms (1)

Experimental Arm- Induction of Mild Hypothermia Protocol

EXPERIMENTAL

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

Interventions

Hypothermia Via Cooling Machine- Arctic Sun 5000 OTHER

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.

Experimental Arm- Induction of Mild Hypothermia Protocol

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research Programs, Department of Cardiovascular and Thoracic Surgery, North Shore University Hospital, Northwell Health

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: September 30, 2020
• Study Start: May 18, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 29, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)