The Mechanism of Dexmedetomidine in Improving Delirium Af... | NCT04127500

Studies
The Mechanism of Dexmedetomidine in Improving Delirium After Cardiac Surgery

NCT04127500

Sponsor

Nanjing First Hospital, Nanjing Medical University

Status

Unknown status

Last Update Posted

Oct 15, 2019Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Dexmedetomidine
Delirium
Cardiac Surgery

Interventions

dexmedetomidine

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

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Jul 31, 2020Estimated

Completion Date

Aug 31, 2020Estimated

First Submitted Date

Oct 12, 2019

First Submission Date that Met QC Criteria

Oct 12, 2019

First Posted Date

Oct 15, 2019Actual

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

Oct 12, 2019

Last Update Posted Date

Oct 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

HONG LIANG, Doctor, Nanjing First Hospital, Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

Nanjing First Hospital, Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

The investigators aim to evaluate the roles of α7nAchR in the mechanisms of dexmedetomidine in improving delirium after cardiac surgery. The results of this study would lay the foundation for revealing the mechanisms of dexmedetomidine improving delirium after cardiac surgery and provide a new idea to the early treatment of delirium.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DEX group	Experimental	use DEX	Drug: dexmedetomidine
control group	No Intervention	use placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dexmedetomidine	Drug	dexmedetomidine	DEX group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
delirium incidence		1 month
α7nAChR level		7 days

Secondary Outcomes

Measure	Description	Time Frame
mechanical ventilation time		7 days
ICU stay time		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICU patients underwent cardiac surgery
age ≥ 60 years

Exclusion Criteria:

Preoperative cognitive decline, mental illness,
preoperative long-term use of hormone patients,
preoperative alcohol dependence,
patients with alcohol withdrawal symptoms

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qiankun Shi, Doctor	Contact	+8613851420762		hlblade@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing First Hospital	Recruiting	Nanjing	Jiangsu	210006	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided