Post-Operative Delirium in Elderly Surgical Patients (STRIDE)

A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients

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

Study Overview

• Status: Completed
• Conditions: Delirium; Hip Fractures
• Intervention / Treatment: Device: Deeper sedation; Device: Moderate sedation

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
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • The Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Observer's Assessment of Awareness/Sedation Scale (OAA/S)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative days up to hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months post-operative
Mortality	death occurring during follow-up period, in one year post-op.	12 months post-operative
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.	1 month (30 days) post-intervention
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.	12 months post-operative

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: December 28, 2007
• First Posted (Estimate): January 11, 2008

Study Record Updates

• Last Update Posted (Actual): June 11, 2018
• Last Update Submitted That Met QC Criteria: May 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Confusion; Hip fractures; Delirium; Femoral neck fractures; Intertrochanteric fractures; Trochanteric fractures; Subtrochanteric fractures
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Leg Injuries; Femoral Fractures; Hip Injuries; Delirium; Hip Fractures
• Other Study ID Numbers: NA_00041873; ACCM Delirium 3; R01AG033615 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No