NCT01574950

Brief Summary

Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. There is very little information available about how often delirium occurs and the complications associated with it. Elderly patients are at high risk for delirium after surgery. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. The results from this study will provide important information on a possible mechanism and predictor of delirium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 26, 2015

Status Verified

October 1, 2015

Enrollment Period

2.3 years

First QC Date

February 16, 2012

Last Update Submit

October 23, 2015

Conditions

Delirium

Keywords

Delirium

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-operative delirium in elderly patients undergoing spine surgery at Johns Hopkins Hospital

    24 months

Secondary Outcomes (1)

  • Severity of postoperative delirium, using Delirium Rating Scale-Revised-1998, in elderly patients undergoing spine surgery.

    24 months

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population is male and female subjects age 70 years and older that are having spine surgery.

You may qualify if:

  • ≥ 70 years old,
  • Undergoing any lumbar spine surgery, posterior cervical spine surgery, or anterior cervical spine surgery \> 2 levels

You may not qualify if:

  • MMSE \< 15
  • Delirium at baseline
  • Inability to speak and understand English
  • Severe hearing impairment, resulting in inability to converse.
  • Planned use of intraoperative ketamine
  • Planned use of intraoperative remifentanil, except for airway management pre-incision.
  • Arterial catheter not planned to be inserted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Charles Brown, MD

    The Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2012

First Posted

April 10, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 26, 2015

Record last verified: 2015-10

Locations

US(1)