Trial Outcomes & Findings for Post-Operative Delirium in Elderly Surgical Patients (NCT NCT00590707)
NCT ID: NCT00590707
Last Updated: 2018-06-11
Results Overview
The presence of delirium is assessed by the confusion assessment method (CAM), during postoperative Day 1 to Day 5 or up to hospital discharge, whichever occurs first. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Postoperative days up to hospital discharge
Results posted on
2018-06-11
Participant Flow
Participant milestones
| Measure |
Deeper Sedation
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the "deeper sedation" arm.
Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.
|
Moderate Sedation
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the "moderate sedation" arm.
Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Operative Delirium in Elderly Surgical Patients
Baseline characteristics by cohort
| Measure |
Deeper Sedation
n=100 Participants
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the "deeper sedation" arm.
Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.
|
Moderate Sedation
n=100 Participants
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the "moderate sedation" arm.
Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.
|
Total
n=200 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Age, Continuous
|
82 years
STANDARD_DEVIATION 7 • n=5 Participants
|
82 years
STANDARD_DEVIATION 8 • n=7 Participants
|
82 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative days up to hospital dischargeThe presence of delirium is assessed by the confusion assessment method (CAM), during postoperative Day 1 to Day 5 or up to hospital discharge, whichever occurs first. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
Outcome measures
| Measure |
Deeper Sedation
n=100 Participants
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the "deeper sedation" arm.
Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.
|
Moderate Sedation
n=100 Participants
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the "moderate sedation" arm.
Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.
|
|---|---|---|
|
Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method
|
39 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 12 months post-operativePopulation: ADL score at 1 year
Ability to perform Activities of Daily Living (ADL) using 6-point Katz activities of daily living scale, assessed at 12 months post-op. The range of the Katz activities of daily living scale is from 0-6, 0 is worse and 6 is best.
Outcome measures
| Measure |
Deeper Sedation
n=100 Participants
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the "deeper sedation" arm.
Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.
|
Moderate Sedation
n=100 Participants
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the "moderate sedation" arm.
Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.
|
|---|---|---|
|
Change in Functional Status
|
4.2 units on a scale
Standard Deviation 1.5
|
4.1 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 12 months post-operativedeath occurring during follow-up period, in one year post-op.
Outcome measures
| Measure |
Deeper Sedation
n=100 Participants
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the "deeper sedation" arm.
Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.
|
Moderate Sedation
n=100 Participants
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the "moderate sedation" arm.
Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.
|
|---|---|---|
|
Mortality
|
14 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 1 month (30 days) post-interventionThe presence of delirium is assessed by the confusion assessment method (CAM), after 1 month postoperative. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
Outcome measures
| Measure |
Deeper Sedation
n=100 Participants
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the "deeper sedation" arm.
Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.
|
Moderate Sedation
n=100 Participants
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the "moderate sedation" arm.
Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.
|
|---|---|---|
|
Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 months post-operativeClinical Dementia Rating consists of 6 domains ("boxes") of function: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain ("box") is rated on a 5-point scale (0= no impairment, 0.5=questionable impairment, 1= mild impairment, 2= moderated impairment, 3= severe impairment. The CDR-SOB score is a sum of these ratings, for a total Sum of boxes ranging from 0-18, where 0=cognitively intact. Increasing sum of boxes score is associated with greater cognitive impairment.
Outcome measures
| Measure |
Deeper Sedation
n=100 Participants
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the "deeper sedation" arm.
Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.
|
Moderate Sedation
n=100 Participants
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the "moderate sedation" arm.
Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.
|
|---|---|---|
|
Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score
|
2.0 units on a scale
Standard Deviation 3.0
|
2.0 units on a scale
Standard Deviation 3.0
|
Adverse Events
Deeper Sedation
Serious events: 15 serious events
Other events: 69 other events
Deaths: 14 deaths
Moderate Sedation
Serious events: 14 serious events
Other events: 69 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Deeper Sedation
n=100 participants at risk
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the "deeper sedation" arm.
Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.
|
Moderate Sedation
n=100 participants at risk
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the "moderate sedation" arm.
Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
orthopedic
|
2.0%
2/100 • Number of events 2 • 1 year
definitions are same as clinical trials.gov definitions
|
2.0%
2/100 • Number of events 2 • 1 year
definitions are same as clinical trials.gov definitions
|
|
Surgical and medical procedures
other postop
|
5.0%
5/100 • Number of events 5 • 1 year
definitions are same as clinical trials.gov definitions
|
2.0%
2/100 • Number of events 2 • 1 year
definitions are same as clinical trials.gov definitions
|
|
Cardiac disorders
cardiaovascular postop complications
|
3.0%
3/100 • Number of events 3 • 1 year
definitions are same as clinical trials.gov definitions
|
3.0%
3/100 • Number of events 3 • 1 year
definitions are same as clinical trials.gov definitions
|
|
Skin and subcutaneous tissue disorders
wound
|
1.0%
1/100 • Number of events 1 • 1 year
definitions are same as clinical trials.gov definitions
|
1.0%
1/100 • Number of events 1 • 1 year
definitions are same as clinical trials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
respiratory
|
1.0%
1/100 • Number of events 1 • 1 year
definitions are same as clinical trials.gov definitions
|
2.0%
2/100 • Number of events 2 • 1 year
definitions are same as clinical trials.gov definitions
|
|
Nervous system disorders
cns
|
2.0%
2/100 • Number of events 2 • 1 year
definitions are same as clinical trials.gov definitions
|
3.0%
3/100 • Number of events 3 • 1 year
definitions are same as clinical trials.gov definitions
|
|
Renal and urinary disorders
urinary tract
|
1.0%
1/100 • Number of events 1 • 1 year
definitions are same as clinical trials.gov definitions
|
1.0%
1/100 • Number of events 1 • 1 year
definitions are same as clinical trials.gov definitions
|
Other adverse events
| Measure |
Deeper Sedation
n=100 participants at risk
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the "deeper sedation" arm.
Deeper sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.
|
Moderate Sedation
n=100 participants at risk
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the "moderate sedation" arm.
Moderate sedation: The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.
|
|---|---|---|
|
Renal and urinary disorders
urinary tract
|
37.0%
37/100 • Number of events 37 • 1 year
definitions are same as clinical trials.gov definitions
|
42.0%
42/100 • Number of events 42 • 1 year
definitions are same as clinical trials.gov definitions
|
|
Skin and subcutaneous tissue disorders
wound
|
4.0%
4/100 • Number of events 4 • 1 year
definitions are same as clinical trials.gov definitions
|
2.0%
2/100 • Number of events 2 • 1 year
definitions are same as clinical trials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
respiratory
|
3.0%
3/100 • Number of events 3 • 1 year
definitions are same as clinical trials.gov definitions
|
5.0%
5/100 • Number of events 5 • 1 year
definitions are same as clinical trials.gov definitions
|
|
Nervous system disorders
cns
|
0.00%
0/100 • 1 year
definitions are same as clinical trials.gov definitions
|
1.0%
1/100 • Number of events 1 • 1 year
definitions are same as clinical trials.gov definitions
|
|
Cardiac disorders
cardiovascualr
|
9.0%
9/100 • Number of events 9 • 1 year
definitions are same as clinical trials.gov definitions
|
10.0%
10/100 • Number of events 10 • 1 year
definitions are same as clinical trials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
orthopedic
|
0.00%
0/100 • 1 year
definitions are same as clinical trials.gov definitions
|
1.0%
1/100 • Number of events 1 • 1 year
definitions are same as clinical trials.gov definitions
|
|
Surgical and medical procedures
other postop
|
16.0%
16/100 • Number of events 16 • 1 year
definitions are same as clinical trials.gov definitions
|
8.0%
8/100 • Number of events 8 • 1 year
definitions are same as clinical trials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place