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Alpha-2 Agonist
Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients (PCS Trial)
Phase 1 & 2
Waitlist Available
Led By Craig Weinert, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days after enrollment
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
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.
Eligible Conditions
- Anxiety
- Acute Respiratory Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 days after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days after enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Aggregate Sedative Exposure During PCS Use (up to 5 Days).
Secondary study objectives
Number of Participants With Adverse Events
Side effects data
From 2020 Phase 4 trial • 798 Patients • NCT0200461357%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Patient controlled sedationExperimental Treatment1 Intervention
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.
Group II: usual sedative practiceActive Control1 Intervention
Subjects will have "usual care" sedation directed by their patient care team with no protocolized restriction on drug doses, selection or duration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
FDA approved
Find a Location
Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
604 Previous Clinical Trials
10,378,386 Total Patients Enrolled
6 Trials studying Anxiety
1,810 Patients Enrolled for Anxiety
University of MinnesotaLead Sponsor
1,436 Previous Clinical Trials
1,621,771 Total Patients Enrolled
8 Trials studying Anxiety
2,430 Patients Enrolled for Anxiety
Hospira, now a wholly owned subsidiary of PfizerIndustry Sponsor
74 Previous Clinical Trials
24,553 Total Patients Enrolled
Craig Weinert, MDPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
15 Total Patients Enrolled