Post-Operative Delirium in Elderly Surgical Patients (STRIDE)

• 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: Johns Hopkins University
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Johns Hopkins University

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.

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 Design

• 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

Arms and Interventions

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)

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

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:

Study Protocol and Statistical Analysis Plan  [PDF] November 19, 2012

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00590707
• Other Study ID Numbers: NA_00041873; ACCM Delirium 3; R01AG033615 ( U.S. NIH Grant/Contract )
• First Posted: January 11, 2008
• 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; Emergence Delirium; Hip Fractures; Fractures, Bone; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Femoral Fractures; Hip Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes