WithdrawnNot Applicable

Mild Hypothermia for COVID-19 ARDS

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

United States0Started 2020-05-18

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Changes in metabolic requirement during and after hypothermia

Timeframe: Every 12 hours through study completion an average of 4 days

Trial details

NCT IDNCT04570462

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More COVID19 ARDS trials