Hip FracturesSTRIDENCT00590707

Post-Operative Delirium in Elderly Surgical Patients

A study testing Deeper sedation and Moderate sedation in people with Hip Fractures and Delirium, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 65 years and older
Conditions the study is for: Hip Fractures, Delirium
What is being tested?: Deeper sedation and Moderate sedation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteUnited States
Study dates: Jan 2005to May 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Hip Fractures, Delirium
Being tested: Deeper sedation, Moderate sedation
Keywords: Hip fractures, Femoral neck fractures, Trochanteric fractures, Intertrochanteric fractures, Subtrochanteric fractures, Delirium, Confusion
Medical subject headings: Hip Fractures, Delirium, Femoral Neck Fractures, Confusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Deeper sedationDevice
Also called Observer's Assessment of Awareness/Sedation Scale (OAA/S)
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 sedationDevice
Also called Observer's Assessment of Awareness/Sedation Scale (OAA/S)
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.

Study groups in NCT00590707
Study group	Role	What they receive
Deeper sedation	Active comparator	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. Receives: Device: Deeper sedation
Moderate sedation	Active comparator	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. Receives: Device: Moderate sedation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Postoperative days up to hospital discharge

Secondary outcomes (4)

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.
Measured: 12 months post-operative
Mortality
death occurring during follow-up period, in one year post-op.
Measured: 12 months post-operative
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.
Measured: 1 month (30 days) post-intervention
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.
Measured: 12 months post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005May 2017

First posted11 Jan 2008 (estimated)
Study startJan 2005
Primary completionMay 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Hip FracturesStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00590707
Sponsor's protocol ID: NA_00041873
Other IDs: ACCM Delirium 3, R01AG033615
Acronym: STRIDE
Status last verified: May 2018
First submitted: 28 Dec 2007
Last updated: 11 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Umoh ME, Sharma A, Leoutsakos JS, Lyketsos CG, Inouye SK, Marcantonio ER, Rosenberg PB, Neufeld KJ, Sieber F, Oh ES. Cognitive Outcomes After Hip Fracture Surgery: The Association of Postoperative Delirium on Previously Cognitively Normal Older Adults. Am J Geriatr Psychiatry. 2026 Jun;34(6):857-866. doi: 10.1016/j.jagp.2025.10.002. Epub 2025 Oct 11.
PubMed 41203484
Sieber F, Neufeld KJ, Gottschalk A, Bigelow GE, Oh ES, Rosenberg PB, Mears SC, Stewart KJ, Ouanes JP, Jaberi M, Hasenboehler EA, Wang NY. Depth of sedation as an interventional target to reduce postoperative delirium: mortality and functional outcomes of the Strategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients randomised clinical trial. Br J Anaesth. 2019 Apr;122(4):480-489. doi: 10.1016/j.bja.2018.12.021. Epub 2019 Feb 4.
PubMed 30857604
Sieber FE, Neufeld KJ, Gottschalk A, Bigelow GE, Oh ES, Rosenberg PB, Mears SC, Stewart KJ, Ouanes JP, Jaberi M, Hasenboehler EA, Li T, Wang NY. Effect of Depth of Sedation in Older Patients Undergoing Hip Fracture Repair on Postoperative Delirium: The STRIDE Randomized Clinical Trial. JAMA Surg. 2018 Nov 1;153(11):987-995. doi: 10.1001/jamasurg.2018.2602.
PubMed 30090923
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.
PubMed 20042557

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures

All Hip Fractures trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients
ClinicalTrials.gov ID: NCT00590707
Acronym / sponsor ID: STRIDE / NA_00041873
Conditions: Hip Fractures, Delirium
Keywords: Hip fractures, Femoral neck fractures, Trochanteric fractures, Intertrochanteric fractures, Subtrochanteric fractures, Delirium, Confusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Jan 2005
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 11 Jan 2008 (estimated)
Results: Posted 11 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Deeper sedation	Active comparator	Device: Deeper sedationPatients 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.
Moderate sedation	Active comparator	Device: Moderate sedationPatients 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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Deeper sedationAlso: Observer's Assessment of Awareness/Sedation Scale (OAA/S)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.	Device	Deeper sedation
Moderate sedationAlso: Observer's Assessment of Awareness/Sedation Scale (OAA/S)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.	Device	Moderate sedation

Primary outcome

Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method
Time frame: Postoperative days up to hospital discharge
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.

4 secondary outcomes

Change in Functional Status
Time frame: 12 months post-operative
Mortality
Time frame: 12 months post-operative
Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method
Time frame: 1 month (30 days) post-intervention
Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score
Time frame: 12 months post-operative

Results and safety

Results posted to the registry on 11 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Deeper Sedation	100	100
Moderate Sedation	100	100

Primary outcome: Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method

Time frame: Postoperative days up to hospital discharge. Count of participants. Unit: Participants

Measure	Deeper Sedation n = 100	Moderate Sedation n = 100
Value	39	34

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Deeper Sedation	15 of 100 (15%)	69 of 100 (69%)	14 of 100
Moderate Sedation	14 of 100 (14%)	69 of 100 (69%)	14 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41203484Umoh ME, Sharma A, Leoutsakos JS, Lyketsos CG, Inouye SK, Marcantonio ER, Rosenberg PB, Neufeld KJ, Sieber F, Oh ES. Cognitive Outcomes After Hip Fracture Surgery: The Association of Postoperative Delirium on Previously Cognitively Normal Older Adults. Am J Geriatr Psychiatry. 2026 Jun;34(6):857-866. doi: 10.1016/j.jagp.2025.10.002. Epub 2025 Oct 11.
Derived from this study: PubMed 30857604Sieber F, Neufeld KJ, Gottschalk A, Bigelow GE, Oh ES, Rosenberg PB, Mears SC, Stewart KJ, Ouanes JP, Jaberi M, Hasenboehler EA, Wang NY. Depth of sedation as an interventional target to reduce postoperative delirium: mortality and functional outcomes of the Strategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients randomised clinical trial. Br J Anaesth. 2019 Apr;122(4):480-489. doi: 10.1016/j.bja.2018.12.021. Epub 2019 Feb 4.
Derived from this study: PubMed 30090923Sieber FE, Neufeld KJ, Gottschalk A, Bigelow GE, Oh ES, Rosenberg PB, Mears SC, Stewart KJ, Ouanes JP, Jaberi M, Hasenboehler EA, Li T, Wang NY. Effect of Depth of Sedation in Older Patients Undergoing Hip Fracture Repair on Postoperative Delirium: The STRIDE Randomized Clinical Trial. JAMA Surg. 2018 Nov 1;153(11):987-995. doi: 10.1001/jamasurg.2018.2602.
Derived from this study: PubMed 20042557Sieber 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.

Related trials for Hip Fractures

Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Frederick E. Sieber, MD principal investigator

Dept. of Anesthesiology and Critical Care Medicine, School of Medicine, The Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Deeper sedation and Moderate sedation in people with Hip Fractures and Delirium, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method (time frame: Postoperative days up to hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00590707, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.