Trial Outcomes & Findings for Use of Dexmedetomidine to Facilitate Extubation in Surgical ICU Patients Who Failed Previous Weaning Attempts (NCT NCT00464490)

NCT ID: NCT00464490

Last Updated: 2014-10-31

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

time from first weaning attempt to successful extubation

Results posted on

2014-10-31

Participant Flow

Total accrual reached 42 of the planned 60; unanticipated common usage of Dexmedetomidine led to difficulty recruiting intubated/sedated patients who had not used it within protocol-specified period prior to enrollment. Also, some providers were not willing to allow patient assignment to the control arm given the popular usage of the drug.

Participant milestones

Participant milestones
Measure	Dexmedetomidine for Extubation (DG) Dexmedomidine infusion to facilitate extubation Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced.	Standard Hospital Protocol (CG) Control. Standard hospital weaning protocol
Overall Study STARTED	21	21
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	11	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexmedetomidine for Extubation (DG) Dexmedomidine infusion to facilitate extubation Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced.	Standard Hospital Protocol (CG) Control. Standard hospital weaning protocol
Overall Study Physician Decision	11	11

Baseline Characteristics

Use of Dexmedetomidine to Facilitate Extubation in Surgical ICU Patients Who Failed Previous Weaning Attempts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine for Extubation (DG) n=10 Participants Dexmedomidine infusion to facilitate extubation Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced.	Standard Hospital Protocol (CG) n=10 Participants Control. Standard hospital weaning protocol	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Ramsay Sedation Scale (RSS)	3.5 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	2.1 units on a scale STANDARD_DEVIATION 1.1 • n=7 Participants	3 units on a scale STANDARD_DEVIATION 3 • n=5 Participants

PRIMARY outcome

Timeframe: time from first weaning attempt to successful extubation

Outcome measures

Outcome measures
Measure	Dexmedetomidine for Extubation (DG) n=10 Participants Dexmedomidine infusion to facilitate extubation Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced.	Standard Hospital Protocol (CG) n=10 Participants Control. Standard hospital weaning protocol
Mechanical Ventilation Time	59.2 hours Standard Deviation 139.4	203.9 hours Standard Deviation 150.7

Adverse Events

Dexmedetomidine for Extubation (DG)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Hospital Protocol (CG)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julin F. Tang, MD, MS

University of California San Francisco

Phone: 415-206-5274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place