COVID19 ARDSNCT04570462
Mild Hypothermia for COVID-19 ARDS
A study testing Hypothermia Via Cooling Machine- Arctic Sun 5000 in people with COVID19 ARDS, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID19 ARDS
- What is being tested?
- Hypothermia Via Cooling Machine- Arctic Sun 5000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID19 ARDS
- Being tested
- Hypothermia Via Cooling Machine- Arctic Sun 5000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermia Via Cooling Machine- Arctic Sun 5000Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hypothermia Via Cooling Machine- Arctic Sun 5000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in metabolic requirement during and after hypothermia
indirect calorimeter measurements (Kcal/day)
Measured: Every 12 hours through study completion an average of 4 days
Secondary outcomes (6)
Changes in oxygen requirements and levels during and after hypothermia
ABG, PaO2 (mmHg)
Measured: Every 12 hours through study completion, an average of 4 days
length of intubation
number of hours intubated
Measured: through study completion, an average of 4 days
Changes in carbon dioxide levels during and after hypothermia
measured by ABG, PaCO2 mmHg
Measured: Every 12 hours through study completion an average of 4 days
does application of hypothermia reduce pro inflammatory response
ESR (mm/hr)
Measured: through study completion an average of 4 days
does application of hypothermia reduce pro inflammatory response
Ferritin (ng/ml)
Measured: through study completion an average of 4 days
does application of hypothermia reduce pro inflammatory response
D Dimer (ng/ml)
Measured: through study completion an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start18 May 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: The study was opened at the close of the peak of COVID. At our institution, there are significantly less COVID patients admitted who qualify for the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19 ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pey-Jen Yu, MD, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570462
- Sponsor's protocol ID
- Protocol 5.18.2020 Approved
- Status last verified
- Sep 2020
- First submitted
- 21 Jul 2020
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Mild Hypothermia for COVID-19 Acute Respiratory Distress
- ClinicalTrials.gov ID
- NCT04570462
- Acronym / sponsor ID
- Protocol 5.18.2020 Approved
- Conditions
- COVID19 ARDS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was opened at the close of the peak of COVID. At our institution, there are significantly less COVID patients admitted who qualify for the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm- Induction of Mild Hypothermia Protocol | Experimental | Other: Hypothermia Via Cooling Machine- Arctic Sun 5000Determination 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypothermia Via Cooling Machine- Arctic Sun 5000Initiate 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. | Other | Experimental Arm- Induction of Mild Hypothermia Protocol |
Primary outcome
Changes in metabolic requirement during and after hypothermia
Time frame: Every 12 hours through study completion an average of 4 days
indirect calorimeter measurements (Kcal/day)
6 secondary outcomes
Changes in oxygen requirements and levels during and after hypothermia
Time frame: Every 12 hours through study completion, an average of 4 days
length of intubation
Time frame: through study completion, an average of 4 days
Changes in carbon dioxide levels during and after hypothermia
Time frame: Every 12 hours through study completion an average of 4 days
does application of hypothermia reduce pro inflammatory response
Time frame: through study completion an average of 4 days
does application of hypothermia reduce pro inflammatory response
Time frame: through study completion an average of 4 days
does application of hypothermia reduce pro inflammatory response
Time frame: through study completion an average of 4 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermia Via Cooling Machine- Arctic Sun 5000 in people with COVID19 ARDS, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in metabolic requirement during and after hypothermia (time frame: Every 12 hours through study completion an average of 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.