Clinical trial NCT04494867: Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation
Official title: Core Warming of COVID-19 Patients Undergoing Mechanical Ventilation: a Randomized, Single Center Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: Advanced Cooling Therapy, Inc., d/b/a Attune Medical
First posted: 2020-07-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the proposed pilot study is to determine if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival.

Detailed description: This is a small scale pilot study to evaluate if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival. This prospective, randomized study will include 20 patients diagnosed with COVID-19, and undergoing mechanical ventilation for the treatment of respiratory failure. Patients will be randomized in a 1:1 fashion with 10 patients (Group A) randomized to undergo core warming, and the other 10 patients (Group B) serving as the control group who will not have the ensoETM device used. Patients randomized to Group A will have core warming initiated in the ICU or other clinical environment in which they are being treated after enrollment and provision of informed consent from appropriate surrogate or legally authorized representative.

Eligibility criteria: Inclusion Criteria:

* Patients above the age of 18 years old.
* Patients with a diagnosis of COVID-19 on mechanical ventilation.
* Patient maximum baseline temperature (within previous 12 hours) \< 38.3°C.
* Patients must have a surrogate or legally authorized representative able to understand and critically review the informed consent form.

Exclusion Criteria:

* Patients without surrogate or legally authorized representative able to provide informed consent.
* Patients with contraindication to core warming using an esophageal core warming device.
* Patients known to be pregnant.
* Patients with \<40 kg of body mass.
* Patients with DNR status.
* Patients with acute stroke, post-cardiac arrest, or multiple sclerosis.

Primary outcomes:
measure: PaO2/FiO2 Ratio
timeFrame: 0, 24, 48, and 72 hours after initiation of core warming
Secondary outcomes:
measure: Cycle Threshold at 72-hours
timeFrame: 72 hours after initiation of core warming
measure: Ventilator-Free Days
timeFrame: Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation
measure: 30-Day Mortality
timeFrame: 30 days after initiation of core warming
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
Study officials:
affiliation: Sharp HealthCare
name: David Willms, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sharp HealthCare
name: Ahmed Salem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans EM, Doctor RJ, Gage BF, Hotchkiss RS, Fuller BM, Drewry AM. The Association of Fever and Antipyretic Medication With Outcomes in Mechanically Ventilated Patients: A Cohort Study. Shock. 2019 Aug;52(2):152-159. doi: 10.1097/SHK.0000000000001368.
citation: Drewry AM, Ablordeppey EA, Murray ET, Dalton CM, Fuller BM, Kollef MH, Hotchkiss RS. Monocyte Function and Clinical Outcomes in Febrile and Afebrile Patients With Severe Sepsis. Shock. 2018 Oct;50(4):381-387. doi: 10.1097/SHK.0000000000001083.
citation: Drewry AM, Ablordeppey EA, Murray ET, Stoll CRT, Izadi SR, Dalton CM, Hardi AC, Fowler SA, Fuller BM, Colditz GA. Antipyretic Therapy in Critically Ill Septic Patients: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 May;45(5):806-813. doi: 10.1097/CCM.0000000000002285.
citation: Drewry AM, Fuller BM, Skrupky LP, Hotchkiss RS. The presence of hypothermia within 24 hours of sepsis diagnosis predicts persistent lymphopenia. Crit Care Med. 2015 Jun;43(6):1165-9. doi: 10.1097/CCM.0000000000000940.
citation: Drewry AM, Fuller BM, Bailey TC, Hotchkiss RS. Body temperature patterns as a predictor of hospital-acquired sepsis in afebrile adult intensive care unit patients: a case-control study. Crit Care. 2013 Sep 12;17(5):R200. doi: 10.1186/cc12894.
citation: Drewry AM, Hotchkiss R, Kulstad E. Response to "Body temperature correlates with mortality in COVID-19 patients". Crit Care. 2020 Jul 24;24(1):460. doi: 10.1186/s13054-020-03186-w. No abstract available.