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  • HP:0002045: Hypothermia
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    HP:0002045: Hypothermia

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (5)


    Name (Synonyms) Correlation
    drug2132 Neuromuscular Blocking Agents Wiki 0.71
    drug1538 Hypothermia Via Cooling Machine- Arctic Sun 5000 Wiki 0.71
    drug1537 Hypothermia Wiki 0.71
    Name (Synonyms) Correlation
    drug109 AT-001 Wiki 0.71
    drug3138 Standard of Care Wiki 0.11

    Correlated MeSH Terms (4)


    Name (Synonyms) Correlation
    D007035 Hypothermia NIH 1.00
    D012127 Respiratory Distress Syndrome, Newborn NIH 0.06
    D055371 Acute Lung Injury NIH 0.06
    Name (Synonyms) Correlation
    D012128 Respiratory Distress Syndrome, Adult NIH 0.05

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There are 2 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
    Conditions
    1. Respiratory Distress Syndrome, Adult
    2. Sars-CoV2
    Interventions
    1. Device: Hypothermia
    2. Drug: Neuromuscular Blocking Agents
    3. 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)
    2 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.

    NCT04570462
    Conditions
    1. COVID19 ARDS
    Interventions
    1. Other: Hypothermia Via Cooling Machine- Arctic Sun 5000
    MeSH:Hypothermia
    HPO:Hypothermia

    Primary Outcomes

    Description: indirect calorimeter measurements (Kcal/day)

    Measure: Changes in metabolic requirement during and after hypothermia

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

    Secondary Outcomes

    Description: ABG, PaO2 (mmHg)

    Measure: Changes in oxygen requirements and levels during and after hypothermia

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

    Description: number of hours intubated

    Measure: length of intubation

    Time: through study completion, an average of 4 days

    Description: measured by ABG, PaCO2 mmHg

    Measure: Changes in carbon dioxide levels during and after hypothermia

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

    Description: ESR (mm/hr)

    Measure: does application of hypothermia reduce pro inflammatory response

    Time: through study completion an average of 4 days

    Description: Ferritin (ng/ml)

    Measure: does application of hypothermia reduce pro inflammatory response

    Time: through study completion an average of 4 days

    Description: D Dimer (ng/ml)

    Measure: does application of hypothermia reduce pro inflammatory response

    Time: through study completion an average of 4 days

    HPO Nodes


    Reports

    Data processed on December 13, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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