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Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1842 | Hypothermia Wiki | 0.82 |
| drug2530 | Neuromuscular Blocking Agents Wiki | 0.82 |
| drug1843 | Hypothermia Via Cooling Machine- Arctic Sun 5000 Wiki | 0.58 |
Navigate: Correlations HPO
There are 3 clinical trials
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.
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 3Description: Adverse events expected during cooling, including hemorrhage, bradycardia, and hypotension.
Measure: Adverse event Time: Randomization through study day 3Description: 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 daysDescription: 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 28Description: 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 28Description: 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 firstDescription: 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 firstDescription: 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 firstDescription: 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 firstDescription: 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 7Description: 24 hour urine volume
Measure: Urine output Time: Daily on study day 1, 2, 3, 4, and 7Description: performed in clinical lab
Measure: comprehensive metabolic panel Time: Daily on study day 1, 2, 3, 4, and 7Description: preformed in clinical lab
Measure: Complete blood count with differential count and platelet count Time: Daily on study day 1, 2, 3, 4, and 7Description: 10 ml blood draw
Measure: Biomarkers Time: Daily on study day 1, 2, 3, 4, and 7Description: performed in clinical lab
Measure: Serum electrolytes Time: Every 8 hours until study hour 60Description: Beside blood glucose testing
Measure: Blood glucose Time: Every 4 hours until study hour 60Description: 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)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.
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)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 daysDescription: 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 28Description: 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 28Description: 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 firstDescription: 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 firstDescription: 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 firstDescription: 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 firstDescription: 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 4Description: 24 hour urine volume
Measure: Urine output Time: Daily on study day 1, 2, 3, 4, and 7Description: 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 7Description: 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 7Description: 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 firstDescription: performed in clinical lab
Measure: Serum electrolytes Time: Performed each evening on study days 1, 2, and 3Description: POC blood glucose testing performed at bedside
Measure: Fingerstick blood glucose level Time: every 6 hour from randomization through study day 3Some 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.
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 daysDescription: 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 daysDescription: number of hours intubated
Measure: length of intubation Time: through study completion, an average of 4 daysDescription: 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 daysDescription: ESR (mm/hr)
Measure: does application of hypothermia reduce pro inflammatory response Time: through study completion an average of 4 daysDescription: Ferritin (ng/ml)
Measure: does application of hypothermia reduce pro inflammatory response Time: through study completion an average of 4 daysDescription: D Dimer (ng/ml)
Measure: does application of hypothermia reduce pro inflammatory response Time: through study completion an average of 4 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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