Trial Outcomes & Findings for Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients (NCT NCT01606852)

NCT ID: NCT01606852

Last Updated: 2018-03-13

Results Overview

Will use the sedation intensity score Scale is based on a score of 1 (full arousal) to 4 (no arousal)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 5 days after enrollment
• Results posted on: 2018-03-13

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	7	8
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients

Baseline characteristics by cohort

Measure	Usual Sedative Practice n=7 Participants 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 n=8 Participants 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.	Total n=15 Participants Total of all reporting groups
Age, Continuous	66.5 years STANDARD_DEVIATION 13.2 • n=5 Participants	66.5 years STANDARD_DEVIATION 13.2 • n=7 Participants	66.5 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days after enrollment

Will use the sedation intensity score Scale is based on a score of 1 (full arousal) to 4 (no arousal)

Outcome measures

Measure	Usual Sedative Practice n=7 Participants 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 n=8 Participants 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.
Aggregate Sedative Exposure During PCS Use (up to 5 Days).	4 units on a scale Interval 1.0 to 4.0	3.5 units on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: During 5 days of study protocol

arterial hypotension, bradycardia, self-extubations, and protocol violations related to drug, pump or both.

Outcome measures

Measure	Usual Sedative Practice n=7 Participants 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 n=8 Participants 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.
Number of Participants With Adverse Events	7 participants	8 participants

Adverse Events

Usual Sedative Practice

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Patient Controlled Sedation

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Usual Sedative Practice n=7 participants at risk 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 n=8 participants at risk 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.
Gastrointestinal disorders GI	71.4% 5/7 • Number of events 5	87.5% 7/8 • Number of events 7
Cardiac disorders Heart	14.3% 1/7 • Number of events 1	50.0% 4/8 • Number of events 4
Infections and infestations Skin	57.1% 4/7 • Number of events 4	50.0% 4/8 • Number of events 4
Nervous system disorders Nervous System	14.3% 1/7 • Number of events 1	25.0% 2/8 • Number of events 2
General disorders Eye/Ear	28.6% 2/7 • Number of events 2	0.00% 0/8
Renal and urinary disorders Urinary	28.6% 2/7 • Number of events 2	50.0% 4/8 • Number of events 4
General disorders Sleep	28.6% 2/7 • Number of events 2	37.5% 3/8 • Number of events 3
General disorders Other	42.9% 3/7 • Number of events 3	62.5% 5/8 • Number of events 5

Additional Information

Craig Weinert MD

University of Minnesota

Phone: 612-624-0999

Email: weine006@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place