NCT05211934

Brief Summary

Delirium is an acute brain lesion characterized by abnormalities of consciousness, attention, cognition and sensation. Many brain diseases such as stroke, traumatic brain injury and intracranial hypertension can lead to cardiac insufficiency, arrhythmia and heart failure. The incidence of postoperative delirium in patients undergoing cardiac surgery is high. Postoperative delirium is a manifestation of brain function injury. The effect of postoperative delirium on postoperative cardiac function in patients undergoing cardiac surgery is worthy of further discussion.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

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

January 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

2.5 years

First QC Date

January 14, 2022

Last Update Submit

January 14, 2022

Conditions

Valvular Surgery

Outcome Measures

Primary Outcomes (1)

  • heart function

    Doses of norepinephrine, epinephrine, dopamine, dobutamine and vasopressin

    up to 60 days

Study Arms (2)

The group with delirium

Other: No intervention

The group without delirium

Other: No intervention

Interventions

No interventionOTHER

No intervention

The group with deliriumThe group without delirium

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing valvular surgery in our hospital were selected. The age was 60 years ≤ age ≤75 years, and gender was not limited. According to the occurrence of postoperative delirium, the patients were divided into postoperative delirium group and Non-postoperative delirium group.

You may qualify if:

  • Patients undergoing valvular surgery
  • Age between 60 to 75

You may not qualify if:

  • Have a history of cerebral infarction before operation
  • Cardiac function was seriously impaired before surgery
  • Neuropsychiatric disorders were present before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anzhen hospital, Beijing

Beijing, Beijing Municipality, 100029, China

RECRUITING

Central Study Contacts

Jun Ma

CONTACT

13370103571majun7689@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The chief of department of anesthesiology

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 27, 2022

Study Start

January 1, 2022

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

January 27, 2022

Record last verified: 2022-01

Locations

CN(1)