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Trial record 1 of 1 for:    Postoperative Delirium in Elderly Patients AND Frederick Sieber
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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
December 28, 2007
January 11, 2008
August 24, 2017
January 2005
May 2017   (Final data collection date for primary outcome measure)
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
Presence of delirium 2, 45, and 90 days after surgery [ Time Frame: 90 days after surgery ]
Complete list of historical versions of study NCT00590707 on ClinicalTrials.gov Archive Site
  • 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
Change in functional status (ADLs, IADLs) at 2, 45, and 90 days after surgery [ Time Frame: 90 days after surgery ]
Not Provided
Not Provided
 
Post-Operative Delirium in Elderly Surgical Patients
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
  • Hip Fractures
  • Delirium
  • 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)
  • 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)
  • 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.
    Intervention: Device: Deeper sedation
  • 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.
    Intervention: Device: Moderate sedation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
May 2017
May 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00590707
NA_00041873
ACCM Delirium 3
R01AG033615 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Frederick Sieber, M.D., Johns Hopkins University
Johns Hopkins University
National Institute on Aging (NIA)
Principal Investigator: Frederick E. Sieber, MD Dept. of Anesthesiology and Critical Care Medicine, School of Medicine, The Johns Hopkins University
Johns Hopkins University
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP