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Sections: Correlations,
Clinical Trials, and HPO
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Navigate: Correlations HPO
There is one clinical trial.
The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients hospitalized in intensive care units for an acute respiratory failure in all countries. This situation has quickly led to massive shortage in masks, mechanical ventilation machines and common medications such as hypnotics. All countries over the world are currently experiencing a major shortage in basic hypnotic medications (propofol, midazolam) in the intensive care as well as in the operating theatre. The Principal Investigator proposes to perform a pilot study assessing the benefit-risk ratio of Remimazolam (a novel benzodiazepine with a short half-life) in the critical care units of Nantes University Hospital during the COVID-19 pandemic.
Description: For Safety: Cardiovascular event: Hypotension will be defined as a Mean Arterial Pressure ≤65mmHg or an increase ≥50% of the dose of norepinephrine (if appropriate), sustained over one hour after the beginning of Remimazolam. For Efficacy: Sedation event: the investigator will check if Remimazolam provides an adequate level of sedation assessed with the Richmond Assessment Sedation Scale. The level of sedation will be set by the attending physician and is usually set at-1/0. The investigator will also monitor the need to use standard hypnotic drugs within this time frame as further medication (propofol, midazolam, dexmedetomidine) in case of Remimazolam inefficacy (Richmond Assessment Sedation Scale).
Measure: composite endpoint including a combination of cardio-vascular and sedation events, from baseline (before infusion) to 8 hours, after the beginning of Remimazolam infusion Time: 8 hours after the beginning of infusion.Description: An exhaustive monitoring of Adverse Events will be performed from Day-0 (inclusion), Day-1 and Day-2 (during infusion), to Day-5 (3 days after discontinuation).
Measure: Adverse Events (all grades), related to Remimazolam. Time: 5 daysDescription: Hemodynamic stability follow-up of heart rate, from day1 to day3.
Measure: Heart rate Time: 3 daysDescription: Hemodynamic stability follow-up with systolic, diastolic and mean arterial pressure from day1 to day3.
Measure: Arterial pressure Time: 3 daysDescription: Hemodynamic stability follow-up with the dose of norepinephrine from day1 to day3.
Measure: Dose of norepinephrine Time: 3 daysDescription: Hemodynamic stability follow-up with electrocardiogram from day1 to day3.
Measure: Electrocardiogram (ECG) Time: 3 daysDescription: The level of sedation will be assessed with clinical scale (Richmond Assessment Sedation Scale, scores from -5:unarousable to+4 : Combative or Bispectral Index, index from 100 (awake subject) to 0 (very deep sleep) .From day1 to day3.
Measure: Sedation. Time: 3 daysDescription: The use or switch to other sedatives (midazolam, dexmedetomidine, propofol) in case of remimazolam inefficacy, will be monitored, from day1 to day3.
Measure: Other sedatives. Time: 3 daysDescription: In minutes, defined as Richmond Assessment Sedation Scale 4 of -1/0, only in non-neurologic patients and if general anesthesia is definitely stopped at the end of remimazolam infusion.
Measure: Wake-up time. Time: 3 daysDescription: maximum plasma concentration of Remimazolam and its metabolites, measured during the infusion and at the end. 9 Pharmacokinetic blood samplings during the infusion, and at Day-3, after Remimazolam discontinuation. In total 9 (nine) blood samples of 2 ml will be collected during the 48-hour infusion and during elimination phase (up to 24 hours post Remimazolam infusion).
Measure: Pharmacokinetics of Remimazolam and its metabolites (CNS 7054): Maximum Plasma Concentration. Time: 3 daysDescription: measured during the infusion and at the end. 9 Pharmacodynamics blood samplings during the infusion, and at Day-3, after Remimazolam discontinuation. In total 9 (nine) blood samples of 2 ml will be collected during the 48-hour infusion and during elimination phase (up to 24 hours post Remimazolam infusion).
Measure: Pharmacodynamics Remimazolam and its metabolites (CNS 7054): steady state plasma levels and elimination. Time: 3 daysDescription: Routine laboratory tests for blood gas will be made within this time frame: from day0 to day3.
Measure: Laboratory parameters : blood gas Time: 4 daysDescription: Routine laboratory tests for haemoglobin will be made within this time frame: from day0 to day3.
Measure: Laboratory parameters: haemoglobin Time: 4 daysDescription: Routine laboratory tests for platelet count will be made within this time frame: from day0 to day3.
Measure: Laboratory parameters: platelet count Time: 4 daysDescription: Routine laboratory tests for white blood cell count will be made within this time frame: from day0 to day3.
Measure: Laboratory parameters: white blood cell count Time: 4 daysDescription: Routine laboratory tests for ionogram will be made within this time frame: from day0 to day3.
Measure: Laboratory parameters: ionogram Time: 4 daysDescription: Routine laboratory tests for creatinine will be made within this time frame: from day0 to day3.
Measure: Laboratory parameters: creatinine Time: 4 daysDescription: Routine laboratory tests for bilirubin will be made within this time frame: from day0 to day3.
Measure: Laboratory parameters: bilirubin Time: 4 daysDescription: Routine laboratory tests for albumin will be made within this time frame: from day0 to day3.
Measure: Laboratory parameters: albumin Time: 4 daysDescription: Routine laboratory tests for liver enzymes will be made within this time frame: from day0 to day3.
Measure: Laboratory parameters: liver enzymes Time: 4 daysDescription: Routine laboratory tests for phosphorus will be made within this time frame: from day0 to day3.
Measure: Laboratory parameters: phosphorus Time: 4 daysDescription: Routine laboratory tests for magnesium will be made within this time frame: from day0 to day3.
Measure: Laboratory parameters: magnesium Time: 4 daysDescription: Extubation failure will be defined as the need to intubate a patient in the 96 hours following extubation.
Measure: Extubation failure defined as the need to intubate a patient in the 96 hours following extubation. Time: 28 daysDescription: Defined as the duration between the initiation and the successful weaning of mechanical ventilation. From Day-1 to ICU discharge or Day-28
Measure: Length of Mechanical ventilation. Time: 28 daysDescription: in the ICU or at Day-28 if the patient is not discharged
Measure: Death. Time: 28 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