NCT04127500

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

October 12, 2019

Last Update Submit

October 12, 2019

Conditions

DexmedetomidineDeliriumCardiac Surgery

Outcome Measures

Primary Outcomes (2)

  • delirium incidence

    1 month

  • α7nAChR level

    7 days

Secondary Outcomes (2)

  • mechanical ventilation time

    7 days

  • ICU stay time

    1 month

Study Arms (2)

DEX group

EXPERIMENTAL

use DEX

Drug: dexmedetomidine

control group

NO INTERVENTION

use placebo

Interventions

dexmedetomidineDRUG

dexmedetomidine

DEX group

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICU patients underwent cardiac surgery
  • age ≥ 60 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Qiankun Shi, Doctor

CONTACT

+8613851420762hlblade@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 12, 2019

First Posted

October 15, 2019

Study Start

August 1, 2019

Primary Completion

July 31, 2020

Study Completion

August 31, 2020

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)