CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D007035: Hypothermia NIH

(Synonyms: Hypothe, Hypothermia)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (5)


Name (Synonyms) Correlation
drug1854 Neuromuscular Blocking Agents Wiki 1.00
drug1068 FAVIRA 200 MG Film Tablet Wiki 1.00
drug1344 Hypothermia Wiki 1.00
drug113 AVIGAN 200 MG Film Tablets Wiki 1.00
drug2698 Standard of Care Wiki 0.18

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D055371 Acute Lung Injury NIH 0.10
D012127 Respiratory Distress Syndrome, Newborn NIH 0.09
D012128 Respiratory Distress Syndrome, Adult NIH 0.08

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002045 Hypothermia HPO 1.00

There is one clinical trial.

Clinical Trials


1 Pilot Randomized Clinical Trial of Therapeutic Hypothermia Plus Neuromuscular Blockade vs. Standard of Care in COVID-19 Patients With Moderate to Severe ARDS - the Cooling to Help Injured Lungs (CHILL) Pilot Study

Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of ~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, and small prospective studies suggest that therapeutic hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients with ARDS; however, shivering is a major complication of TH, often requiring paralysis with neuromuscular blocking agents (NMBA) to control. Since the recently completed NHLBI PETAL ROSE trial showed that NMBA had no effect (good or bad) in patients with moderate to severe ARDS, the investigators sought to evaluate whether TH combined with NMBA is beneficial in patients with ARDS. The investigators are scheduled to begin enrolling in a Department of Defense-funded Phase IIb multicenter RCT of TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature management in patients with ARDS with time on ventilator as the primary outcome. Since COVID-19 is now the most common cause of ARDS, we are conducting a pilot study to examine the safety and feasibility of including patients with COVID-19-associated ARDS in our upcoming trial. In this pilot, we will randomize 20 patients with COVID-19 and ARDS to either TH+NMBA for 48h or usual temperature management. The primary outcome is achieving and maintaining the target temperature. Secondary outcomes include safety, physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers collected on days 0, 1, 2, 3, 4, and 7.

NCT03376854 Respiratory Distress Syndrome, Adult Sars-CoV2 Device: Hypothermia Drug: Neuromuscular Blocking Agents Device: Standard of Care
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Hypothermia
HPO:Hypothermia

Primary Outcomes

Description: The total time in hours from beginning of cooling to beginning of rewarming during which the patient's core temperature was within the target range of 34-35°C.

Measure: Targeted temperature compliance

Time: Randomization through day 3

Secondary Outcomes

Description: Adverse events expected during cooling, including hemorrhage, bradycardia, and hypotension.

Measure: Adverse event

Time: Randomization through study day 3

Description: Total number of days alive and not admitted to the ICU in the first 28 days after

Measure: 28-day ICU-free days

Time: Calculated at study day 28 or death (whichever occurs first)

Description: 28-day, 60-day, and 90-day mortality

Measure: Survival

Time: calculated at 28, 60, and 90 days

Description: SOFA score excluding neurologic component - based on PaO2/FiO2 (0-4), BP and pressor requirement (0-4), bilirubin level (0-4), platelet count (0-4), and creatinine (0-14) with total composite score 0-20

Measure: non neurologic Sequential Organ Failure (SOFA) scores

Time: At enrollment and study days 1, 2, 3, 4, 7, and 28

Description: Pulse ox reading

Measure: Oxygen saturation (SpO2)

Time: Measured at enrollment, every 4 hours on enrollment day, then once on day 2, 3, 4, 7 and 28

Description: On machine initiated breath

Measure: Plateau airway pressure

Time: Measured at enrollment, every 4 hours on enrollment day, then once on day 2, 3, 4, and 7 or until extubation whichever occurs first

Description: Direct ventilator measurement on machine initiated breath

Measure: Mean airway pressure

Time: Measured at enrollment, every 4 hours on enrollment day, then once on day 2, 3, 4, and 7 or until extubation whichever occurs first

Description: Plateau pressure - PEEP (machine initiated breath)

Measure: Airway driving pressure

Time: Measured at enrollment, every 4 hours on enrollment day, then once on day 2, 3, 4, and 7 or until extubation whichever occurs first

Description: Mean airway pressure x 100 x FiO2/SpO2

Measure: Oxygen saturation index

Time: Measured at enrollment, every 4 hours on enrollment day, then once on day 2, 3, 4, and 7 or until extubation whichever occurs first

Description: Measured continuously from iv catheter, urinary catheter, or esophageal probe.

Measure: Core temperature

Time: Measured continuously and recorded at enrollment, every 2 hours on the day of enrollment, and mornings on study day 2, 3, 4, and 7

Description: 24 hour urine volume

Measure: Urine output

Time: Daily on study day 1, 2, 3, 4, and 7

Description: performed in clinical lab

Measure: comprehensive metabolic panel

Time: Daily on study day 1, 2, 3, 4, and 7

Description: preformed in clinical lab

Measure: Complete blood count with differential count and platelet count

Time: Daily on study day 1, 2, 3, 4, and 7

Description: 10 ml blood draw

Measure: Biomarkers

Time: Daily on study day 1, 2, 3, 4, and 7

Description: performed in clinical lab

Measure: Serum electrolytes

Time: Every 8 hours until study hour 60

Description: Beside blood glucose testing

Measure: Blood glucose

Time: Every 4 hours until study hour 60

Description: Total number of days alive and not on a ventilator in the first 28 days after enrollment

Measure: 28-day ventilator-free days

Time: Calculated at study day 28 or death (whichever occurs first)


HPO Nodes