Post-Operative Delirium in Elderly Surgical Patients (STRIDE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Frederick Sieber, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00590707
First received: December 28, 2007
Last updated: October 22, 2013
Last verified: October 2013
  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: Maintenance of level of awareness by use of a BIS monitor & the OASS.
Device: Maintenance of level of awareness by use of a BIS monitor and the OASS.

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


Estimated Enrollment: 210
Study Start Date: January 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair at a BIS score of 50-60. This is the "deeper sedation" arm.
Device: Maintenance of level of awareness by use of a BIS monitor & the OASS.
The level of awareness in this arm, as measured by the BIS score, will be kept at 50-60.
Other Names:
  • BIS
  • BIS Monitor
  • Bi-Spectral Analysis Monitor
Active Comparator: 2
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair at a BIS score of 70-80. This is the "moderate sedation" arm.
Device: Maintenance of level of awareness by use of a BIS monitor and the OASS.
The level of awareness in this arm, as measured by the BIS score, will be kept at 70-80.
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
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 COPD;
  • has severe 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

Contacts
Contact: Frederick E. Sieber, MD 410-550-0942 fsieber1@jhmi.edu
Contact: Michael D. Sklar, MA 410-550-1542 msklar1@jhmi.edu

Locations
United States, Maryland
The Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Frederick E. Sieber, MD         
Sub-Investigator: Simon Mears, MD, PhD         
Sub-Investigator: Allan Gottschalk, MD, PhD         
Sub-Investigator: Soudibeh Banankhan, MS         
Sub-Investigator: Esther Oh, MD         
Sub-Investigator: Paul Rosenberg, MD         
Sub-Investigator: Kori A. Kindbom, MA         
Sub-Investigator: Rachel A. Burns, BA         
Sub-Investigator: Michael D. Sklar, MA         
Sub-Investigator: Karin J. Neufeld, MD, MPH         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Frederick E. Sieber, MD Dept. of Anesthesiology and Critical Care Medicine, School of Medicine, The Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional 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
Study First Received: December 28, 2007
Last Updated: October 22, 2013
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:
Hip Injuries
Delirium
Hip Fractures
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 16, 2014