Post-Operative Delirium in Elderly Surgical Patients

Delirium Clinical Trial

— STRIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590707
• Other study ID #: NA_00041873
• Secondary ID: ACCM Delirium 3R
• Status: Completed
• Phase: N/A
• Start date: January 2005
• Est. completion date: May 2017

Study information

• Verified date: May 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Hip Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mortality	death occurring during follow-up period, in one year post-op.	12 months post-operative
Secondary	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
Secondary	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