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Post-Operative Delirium in Elderly Surgical Patients (STRIDE)

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ClinicalTrials.gov Identifier: NCT00590707
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.

Condition or disease Intervention/treatment Phase
Hip Fractures Delirium Device: Deeper sedation Device: Moderate sedation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients
Study Start Date : January 2005
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: 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.
Other Name: Observer's Assessment of Awareness/Sedation Scale (OAA/S)

Active Comparator: 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.
Device: 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.
Other Name: Observer's Assessment of Awareness/Sedation Scale (OAA/S)




Primary Outcome Measures :
  1. Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method [ Time Frame: Postoperative days up to hospital discharge ]
    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 :
  1. Change in Functional Status [ Time Frame: 12 months post-operative ]
    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.

  2. Mortality [ Time Frame: 12 months post-operative ]
    death occurring during follow-up period, in one year post-op.

  3. Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method [ Time Frame: 1 month (30 days) post-intervention ]
    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.

  4. Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score [ Time Frame: 12 months post-operative ]
    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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590707


Locations
United States, Maryland
The Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Frederick E. Sieber, MD Dept. of Anesthesiology and Critical Care Medicine, School of Medicine, The Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00590707     History of Changes
Other Study ID Numbers: NA_00041873
ACCM Delirium 3
R01AG033615 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2008    Key Record Dates
Results First Posted: June 11, 2018
Last Update Posted: June 11, 2018
Last Verified: May 2018

Product Manufactured in and Exported from the U.S.: No

Keywords provided by Johns Hopkins University:
Hip fractures
Femoral neck fractures
Trochanteric fractures
Intertrochanteric fractures
Subtrochanteric fractures
Delirium
Confusion

Additional relevant MeSH terms:
Delirium
Hip Fractures
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries