Post-Operative Delirium in Elderly Surgical Patients (STRIDE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Frederick Sieber, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00590707
First received: December 28, 2007
Last updated: June 6, 2016
Last verified: June 2016
  Purpose
This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.

Condition Intervention
Hip Fractures
Delirium
Device: Deeper sedation
Device: Moderate sedation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Presence of delirium [ Time Frame: Postoperative days 1-5; 1 mon. after surgery; & 1 yr. after surgery ] [ Designated as safety issue: No ]
    Memory/thinking testing


Secondary Outcome Measures:
  • Change in functional status [ Time Frame: 1 mon. & 1 yr. after surgery ] [ Designated as safety issue: No ]
    Ability to perform Activities of Daily Living; strength and walking testing


Enrollment: 200
Study Start Date: January 2005
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 at a Bispectral index (BIS) score of 50-60. This is the "deeper sedation" arm.
Device: Deeper sedation
The depth of sedation, as measured by the Bispectral index (BIS) score and the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at a BIS value of 50-60 and/or an OAA/S score of 0.
Other Names:
  • BIS
  • BIS Monitor
  • Bi-Spectral Analysis Monitor
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 at a Bispectral index (BIS) score of 70-80. This is the "moderate sedation" arm.
Device: Moderate sedation
The depth of sedation, as measured by the Bispectral index (BIS) score and the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at a BIS value of 70-80 and/or an OAA/S score of 4-5.
Other Names:
  • BIS
  • BIS Monitor
  • Bi-Spectral Analysis Monitor

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.
  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frederick Sieber, M.D., Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00590707     History of Changes
Other Study ID Numbers: NA_00041873  ACCM Delirium 3  R01AG033615 
Study First Received: December 28, 2007
Last Updated: June 6, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 23, 2016