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Post-Operative Delirium in Elderly Surgical Patients (STRIDE)

Primary Purpose

Hip Fractures, Delirium

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deeper sedation
Moderate sedation
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Fractures focused on measuring Hip fractures, Femoral neck fractures, Trochanteric fractures, Intertrochanteric fractures, Subtrochanteric fractures, Delirium, Confusion

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • is 65 years of age or older at admission;
  • has surgical treatment of a traumatic hip fracture;
  • has participating surgeon;
  • has Mini-Mental Status Exam score of 15 or higher;
  • able to read/write/speak/hear/understand English;
  • gives informed consent;
  • receives spinal anesthesia

Exclusion Criteria:

  • receives general anesthesia;
  • does not write/write/speak/hear/understand English;
  • has severe chronic obstructive pulmonary disease (COPD);
  • has severe congestive heart failure (CHF);
  • has Mini-Mental Status Exam score less than 15;
  • declines to give informed consent;
  • age less than 65 years at admission;
  • attending surgeon does not participate in study

Sites / Locations

  • The Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Deeper sedation

Moderate sedation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method
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.

Secondary Outcome Measures

Change in Functional Status
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.
Mortality
death occurring during follow-up period, in one year post-op.
Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method
The 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.
Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score
Clinical 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.

Full Information

First Posted
December 28, 2007
Last Updated
May 11, 2018
Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00590707
Brief Title
Post-Operative Delirium in Elderly Surgical Patients
Acronym
STRIDE
Official Title
A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.
Detailed Description
We give sedative drugs to patients having spinal anesthesia so they are "asleep" (sedated) while we are fixing their broken hips. The spinal anesthesia provides pain relief at the site of surgery, while the sedative drugs keep people "asleep" during the procedure. We want to find out whether the amount of sedation we give might (1) make patients be confused when they wake up or (2) have anything to do with how well patients can do their ordinary daily routines a few months after their surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Delirium
Keywords
Hip fractures, Femoral neck fractures, Trochanteric fractures, Intertrochanteric fractures, Subtrochanteric fractures, Delirium, Confusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deeper sedation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Moderate sedation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Deeper sedation
Other Intervention Name(s)
Observer's Assessment of Awareness/Sedation Scale (OAA/S)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Moderate sedation
Other Intervention Name(s)
Observer's Assessment of Awareness/Sedation Scale (OAA/S)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method
Description
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.
Time Frame
Postoperative days up to hospital discharge
Secondary Outcome Measure Information:
Title
Change in Functional Status
Description
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.
Time Frame
12 months post-operative
Title
Mortality
Description
death occurring during follow-up period, in one year post-op.
Time Frame
12 months post-operative
Title
Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method
Description
The 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.
Time Frame
1 month (30 days) post-intervention
Title
Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score
Description
Clinical 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.
Time Frame
12 months post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: is 65 years of age or older at admission; has surgical treatment of a traumatic hip fracture; has participating surgeon; has Mini-Mental Status Exam score of 15 or higher; able to read/write/speak/hear/understand English; gives informed consent; receives spinal anesthesia Exclusion Criteria: receives general anesthesia; does not write/write/speak/hear/understand English; has severe chronic obstructive pulmonary disease (COPD); has severe congestive heart failure (CHF); has Mini-Mental Status Exam score less than 15; declines to give informed consent; age less than 65 years at admission; attending surgeon does not participate in study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick E. Sieber, MD
Organizational Affiliation
Dept. of Anesthesiology and Critical Care Medicine, School of Medicine, The Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30857604
Citation
Sieber F, Neufeld KJ, Gottschalk A, Bigelow GE, Oh ES, Rosenberg PB, Mears SC, Stewart KJ, Ouanes JP, Jaberi M, Hasenboehler EA, Wang NY. Depth of sedation as an interventional target to reduce postoperative delirium: mortality and functional outcomes of the Strategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients randomised clinical trial. Br J Anaesth. 2019 Apr;122(4):480-489. doi: 10.1016/j.bja.2018.12.021. Epub 2019 Feb 4.
Results Reference
derived
PubMed Identifier
30090923
Citation
Sieber FE, Neufeld KJ, Gottschalk A, Bigelow GE, Oh ES, Rosenberg PB, Mears SC, Stewart KJ, Ouanes JP, Jaberi M, Hasenboehler EA, Li T, Wang NY. Effect of Depth of Sedation in Older Patients Undergoing Hip Fracture Repair on Postoperative Delirium: The STRIDE Randomized Clinical Trial. JAMA Surg. 2018 Nov 1;153(11):987-995. doi: 10.1001/jamasurg.2018.2602.
Results Reference
derived
PubMed Identifier
20042557
Citation
Sieber FE, Zakriya KJ, Gottschalk A, Blute MR, Lee HB, Rosenberg PB, Mears SC. Sedation depth during spinal anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010 Jan;85(1):18-26. doi: 10.4065/mcp.2009.0469. Erratum In: Mayo Clin Proc. 2010 Apr;85(4):400. Dosage error in article text.
Results Reference
derived

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Post-Operative Delirium in Elderly Surgical Patients

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