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| ID | Type | Description | Link |
|---|---|---|---|
| R21NR012795 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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Mechanical ventilation (MV) is the most frequently used life-support modality in intensive care units (ICUs). To reduce anxiety, stress and promote tolerance of MV, nurses frequently administer a variety of sedative medications to their patients based on subjective observations.
The investigators hypothesize that patient-controlled sedation, compared to clinician-directed sedation, will decrease sedative exposure while decreasing patient anxiety during the episode of mechanical ventilation.
A study to determine whether critically ill patients, during a substantial portion of their time on mechanical ventilation, can reduce anxiety symptoms better with PCS than their caregivers while reducing over-sedation, duration of mechanical ventilation and length of ICU stay will require hundreds of subjects enrolled on a multi-day protocol. However, patient-controlled sedation has been used in less than 20 patients and only for less than 24 hours. Therefore this study is designed to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual sedative practice | No Intervention | Subjects will have "usual care" sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration. | |
| Patient controlled sedation | Experimental | Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Aggregate Sedative Exposure During PCS Use (up to 5 Days). | Will use the sedation intensity score Scale is based on a score of 1 (full arousal) to 4 (no arousal) | 5 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | arterial hypotension, bradycardia, self-extubations, and protocol violations related to drug, pump or both. | During 5 days of study protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Weinert, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Sedative Practice | Subjects will have "usual care" sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration. |
| FG001 | Patient Controlled Sedation | Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse. Dexmedetomidine: loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Sedative Practice | Subjects will have "usual care" sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration. |
| BG001 | Patient Controlled Sedation |
| 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 | Aggregate Sedative Exposure During PCS Use (up to 5 Days). | Will use the sedation intensity score Scale is based on a score of 1 (full arousal) to 4 (no arousal) | Posted | Number | 95% Confidence Interval | units on a scale | 5 days after enrollment |
|
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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 | Usual Sedative Practice | Subjects will have "usual care" sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI | Gastrointestinal disorders | MEDRa | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Weinert MD | University of Minnesota | 612-624-0999 | weine006@umn.edu |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse.
Dexmedetomidine: loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Adverse Events | arterial hypotension, bradycardia, self-extubations, and protocol violations related to drug, pump or both. | Posted | Number | participants | During 5 days of study protocol |
|
|
|
| 0 |
| 7 |
| 7 |
| 7 |
| EG001 | Patient Controlled Sedation | Subjects will be given the hand actuator connected to a Lifecare PCA Infusion System in the PCA + continuous mode with the syringe filled with 4 ucg/ml of dexmedetomidine. A loading dose (0.5 mcg/kg) will be given followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Bedside RNs will adjust the basal rate to a maximum of based on the number of bolus requests in the prior two hours. Subjects can also receive bolus supplemental sedative medications (benzodiazepines and/or opioids)if needed in the judgment of the patient-care nurse. Dexmedetomidine: loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days. | 0 | 8 | 7 | 8 |
| Heart | Cardiac disorders | MedRa | Systematic Assessment |
|
| Skin | Infections and infestations | MedRa | Systematic Assessment |
|
| Nervous System | Nervous system disorders | MedRa | Systematic Assessment |
|
| Eye/Ear | General disorders | Medra | Systematic Assessment |
|
| Urinary | Renal and urinary disorders | Medra | Systematic Assessment |
|
| Sleep | General disorders | Medra | Systematic Assessment |
|
| Other | General disorders | Medra | Systematic Assessment |
|
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