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drug and placebo unavailable
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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (> 24 hours) in critically ill patients who require mechanical ventilation.
Mechanically ventilated critically ill patients are routinely given sedative and analgesic medications to relieve pain and anxiety associated with intubation, mechanical ventilation, and critical care in general. While integral in minimizing discomfort, these medications may increase mechanical ventilation time, the duration of intensive care unit (ICU) stay, ICU complications (e.g. delirium, ventilator associated pneumonia, venous thromboembolism), the morbidity associated with critical illness, and patient mortality. This study compares two sedative medications that have been used in patients who require a mechanical ventilator. Enrolled patients will be randomly assigned to receive propofol or dexmedetomidine for sedation while they require ventilatory support. All patients will also receive the pain medication fentanyl as needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. |
|
| Propofol | Active Comparator | Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Days With Delirium | delirium assessment using CAM-ICU | daily up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score | Richmond Agitation Sedation Scale (RASS). This is a validated scale that measures level of sedation. The scale ranges from -5 to +4. -5 refers to a state where one is unarousable, +4 refers to a state where one is combative. The median and inter-quartile range over all daily assessments will be provided. | Daily up to day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Kress, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine | Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2) Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility |
| FG001 | Propofol | Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2) Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine | Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2) Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Days With Delirium | delirium assessment using CAM-ICU | Study terminated early due to inability to maintain study drug supply in investigational pharmacy. | Posted | Median | Inter-Quartile Range | proportion of days | daily up to 28 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine | Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2) Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Kress | University of Chicago | 773-702-6790 | jkress@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| D005283 | Fentanyl |
| D008874 | Midazolam |
| D012149 | Restraint, Physical |
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Propofol | Drug | continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS |
|
|
| Fentanyl | Drug | 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale |
|
| Midazolam | Drug | 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2) |
|
|
| Physical and Occupational Therapy | Behavioral | Daily therapy sessions targeting range of motion, strength, and mobility |
|
| Number of Patients Completing Mobility Milestones | Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently | Daily through day 28 |
| Days on Ventilator | 60 days from enrollment |
| Days in ICU | 60 days from enollment |
| Mortality | 28 days from enrollment |
| Number of Participants With ICU Complications | daily through day 28 |
| Number of Patients Requiring Fentanyl | during infusion of study medication up to day 28 |
| Number of Patients Requiring Midazolam | during infusion of study medication through day 28 |
| Days in Hospital | 60 days from enrollment |
| Number of Patients Completing Activities of Daily Living | activities of daily living: eating, bathing, dressing, grooming, toileting | daily through day 28 |
| Number of Adverse Medication Effects | duration of infusion of study medication up to 28 days |
| BG001 | Propofol | Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2) Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Propofol | Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2) Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility |
|
|
| Secondary | Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score | Richmond Agitation Sedation Scale (RASS). This is a validated scale that measures level of sedation. The scale ranges from -5 to +4. -5 refers to a state where one is unarousable, +4 refers to a state where one is combative. The median and inter-quartile range over all daily assessments will be provided. | Posted | Median | Inter-Quartile Range | score on a scale | Daily up to day 28 |
|
|
|
| Secondary | Number of Patients Completing Mobility Milestones | Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently | Posted | Count of Participants | Participants | Daily through day 28 |
|
|
|
| Secondary | Days on Ventilator | Posted | Median | Inter-Quartile Range | days | 60 days from enrollment |
|
|
|
| Secondary | Days in ICU | Posted | Median | Inter-Quartile Range | days | 60 days from enollment |
|
|
|
| Secondary | Mortality | Posted | Count of Participants | Participants | 28 days from enrollment |
|
|
|
| Secondary | Number of Participants With ICU Complications | Posted | Count of Participants | Participants | daily through day 28 |
|
|
|
| Secondary | Number of Patients Requiring Fentanyl | Posted | Count of Participants | Participants | during infusion of study medication up to day 28 |
|
|
|
| Secondary | Number of Patients Requiring Midazolam | Posted | Count of Participants | Participants | during infusion of study medication through day 28 |
|
|
|
| Secondary | Days in Hospital | Posted | Median | Inter-Quartile Range | days | 60 days from enrollment |
|
|
|
| Secondary | Number of Patients Completing Activities of Daily Living | activities of daily living: eating, bathing, dressing, grooming, toileting | Posted | Count of Participants | Participants | daily through day 28 |
|
|
|
| Secondary | Number of Adverse Medication Effects | Posted | Number | number of events | duration of infusion of study medication up to 28 days |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Propofol | Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2) Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility | 0 | 21 | 0 | 21 |
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| D012140 | Respiratory Tract Diseases |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |