CSF Cholinergic Biomarkers and Postoperative Cognitive Ch... | NCT02063542

Studies
CSF Cholinergic Biomarkers and Postoperative Cognitive Change

NCT02063542

Sponsor

RenJi Hospital

Status

Completed

Last Update Posted

May 22, 2019Actual

Enrollment

102Actual

Phase

Not provided

Conditions

Necrosis of Femoral Head
Knee Osteoarthritis
Fracture of Lower Limb

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014Actual

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Feb 8, 2014

First Submission Date that Met QC Criteria

Feb 12, 2014

First Posted Date

Feb 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2019

Last Update Posted Date

May 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Previous study demonstrated that the condition of central cholinergic nerve is important for the postoperative cognitive dysfunction. In present study investigators hypothesized that the acetylcholine concentration in the cerebral spinal fluid is associated to the postoperative cognitive changes in aged patients undergoing osteopathic surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

102Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Short-term postoperative cognitive dysfunction rate		The day before surgery and 7 days after surgery (or before leave hospital)
Concentration of Acetylcholine in CSF		During spinal anesthesia
Concentration of choline acetyltransferase in CSF		During spinal anesthesia
Concentration of acetylcholinesterase in CSF		During spinal anesthesia

Secondary Outcomes

Measure	Description	Time Frame
Long-term postoperative cognitive dysfunction rate		Two months after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elder than 60 years old
Spoke proficient Mandarin Chinese
Agree to undergoing spinal plus general anesthesia
Selected total knee replacement surgery

Exclusion Criteria:

Patients with neurological and/or psychiatric diseases, including AD, stroke and psychosis
Have contraindication for spinal anesthesia such as clotting disorder local infection in the puncture site
Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
Several audition or vision disorder
Unwillingness to comply with the protocol or procedures.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Aged patients undergoing total knee replacement surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Diansan Su, Dr.	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji hospital, School of Medicine, Shanghai Jiaotong University		Shanghai	Shanghai Municipality	200127	China

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided