We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Postoperative Delirium in Elderly Patients AND Frederick Sieber
Previous Study | Return to List | Next Study

Post-Operative Delirium in Elderly Surgical Patients (STRIDE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00590707
First Posted: January 11, 2008
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Frederick Sieber, M.D., Johns Hopkins University
  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
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

Resource links provided by NLM:


Further study details as provided by Frederick Sieber, M.D., Johns Hopkins University:

Primary Outcome Measures:
  • Presence of delirium [ Time Frame: The primary outcome is the impact of the intervention on the incidence of delirium during postoperative Day 1 to Day 5 or to hospital discharge, whichever occurs first. ]
    Memory/thinking testing


Secondary Outcome Measures:
  • Change in functional status [ Time Frame: change in functional outcomes from pre-operative test to 1-month and 12-month follow-up: activities of daily living (ADL) and instrumental ADL (IADL); grip strength; timed chair rise; and timed 3-meter walk ]
    Ability to perform Activities of Daily Living; strength and walking testing

  • mortality [ Time Frame: mortality at one year (12 months) after surgery, ]
    death during followup period

  • delirium [ Time Frame: The secondary outcomes are delirium at 1-month (30 days), and in-hospital delirium at 1-5 days stratified by baseline co-morbidities. ]
    primarily interested in interaction between comorbid status and intervention

  • clinical dementia rating [ Time Frame: change in clinical dementia rating between the pre-operative test and 12-month follow-up ]
    change in cognitive function during followup


Enrollment: 200
Study Start Date: January 2005
Study Completion Date: May 2017
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, 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)

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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
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
  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 ( U.S. NIH Grant/Contract )
First Submitted: December 28, 2007
First Posted: January 11, 2008
Last Update Posted: August 24, 2017
Last Verified: August 2017

Keywords provided by Frederick Sieber, M.D., 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