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D007035: 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 (11)


Name (Synonyms) Correlation
drug1582 Hypothermia Wiki 1.00
drug2176 Neuromuscular Blocking Agents Wiki 1.00
drug3755 Zinc Sulfate Wiki 0.71
Name (Synonyms) Correlation
drug116 ASTX660 Wiki 0.71
drug1744 Itraconazole Wiki 0.41
drug2044 Midazolam Wiki 0.32
drug1093 Doxycycline Wiki 0.32
drug3231 Standard of care Wiki 0.15
drug364 Azithromycin Wiki 0.12
drug3221 Standard of Care Wiki 0.12
drug1520 Hydroxychloroquine Wiki 0.07

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D012127 Respiratory Distress Syndrome, Newborn NIH 0.13
D055371 Acute Lung Injury NIH 0.13
D012128 Respiratory Distress Syndrome, Adult NIH 0.11

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002045 Hypothermia HPO 0.71

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 Cooling to Help Injured Lungs (CHILL) Phase IIB Randomized Control Trial of Therapeutic Hypothermia in Patients With ARDS

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 CHILL trial is designed to evaluate whether TH combined with NMBA is beneficial in patients with ARDS. This Phase IIb randomized clinical trial is funded by the Department of Defense to compare TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature management in patients in 14 clinical centers with the Clinical Coordination Center and Data Coordinating Center at University of Maryland Baltimore. Planned enrollment is 340 over ~3.5 years of the 4-year contract. Since COVID-19 is currently the most common cause of ARDS, randomization will be stratified on COVID-19 status and patients with COVID-19 limited to no more than one-third of budgeted enrollment per year. Primary outcome is 28-day ventilator-free days. Secondary outcomes include safety, physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers collected at baseline and on days 1, 2, 3, 4, and 7.

NCT04545424
Conditions
  1. Respiratory Distress Syndrome, Adult
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: Total number of days alive and not on a ventilator in the first 28 days after enrollment

Measure: 28-day ventilator-free days (VFDs)

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

Secondary Outcomes

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 2 hours on enrollment day, then once on day 2, 3, 4, 7 and 28

Description: On ventilator-imitated breath; measured at enrollment, every 4 hours on enrollment day, then Measured at randomization and daily on study days 1, 2, 3, 4, and 7 or until extubation whichever occurs firstinitiated breath

Measure: Plateau airway pressure

Time: Measured at randomization and daily as close to 0800 as possible on study days 1 2, 3, 4, and 7 or until extubation whichever occurs first

Description: Measured from ventilator during machine initiated breath

Measure: Mean airway pressure

Time: Measured at randomization and daily as close to 0800 as possible on study days 1 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 randomization and daily as close to 0800 as possible on study days 1 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 randomization and daily as close to 0800 as possible on study days 1 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 randomization and then every 2 hours through study day 4

Description: 24 hour urine volume

Measure: Urine output

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

Description: 7 ml of blood collected in serum separator tubes; assay preformed in clinical lab

Measure: comprehensive metabolic panel blood test (includes sodium, potassium, chloride, bicarb, BUN, creatinine, glucose, albumin, total protein, AST, SLT, alkaline phosphatase, and bilirubin)

Time: At randomization and each morning on study days 1, 2, 3, 4, and 7

Description: 7 ml of blood collected in purple top tube; assay preformed in clinical lab

Measure: Complete blood count with differential count and platelet count

Time: At randomization and each morning on study days 1, 2, 3, 4, and 7

Description: 12 ml blood draw in two green top tubes

Measure: Plasma biomarkers measured by immunoassay and including IL-1ß, IL-6, IL-8, IL-18, surfactant protein D, soluble ICAM-1, MMP8, and soluble TNF receptor-I)

Time: Collected at randomization and as close to 0800 as possible on study days 1 2, 3, 4, and 7 or until extubation whichever occurs first

Description: performed in clinical lab

Measure: Serum electrolytes

Time: Performed each evening on study days 1, 2, and 3

Description: POC blood glucose testing performed at bedside

Measure: Fingerstick blood glucose level

Time: every 6 hour from randomization through study day 3

HPO Nodes


Reports

Data processed on September 26, 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.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook