NCT04884841

Brief Summary

Patients undergoing cardiac surgery is routinely performed in clinical scenarios, highly postoperative morbidities and long-term mortality should be modified. A simple risk prediction model incorporating risk factors can help guide clinical decision making, patient counseling and treatment planning.

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
70,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

10 years

First QC Date

May 9, 2021

Last Update Submit

May 12, 2021

Conditions

Outcome Measures

Primary Outcomes (11)

  • postoperative complications: acute kidney injury

    Diagnosed acute kidney injury (KDIGO)

    30 dyas

  • postoperative complications: Chronic Kidney disease

    Diagnosed Chronic Kidney disease

    30 days, as follow up

  • postoperative complications: Infection

    Diagnosed infection

    30 days

  • postoperative complications: delirium

    Diagnosed delirium (CAM,CAM-ICU)

    30 days

  • postoperative complications: MACCE

    Diagnosed MACCE

    30 days, as follow up

  • postoperative complications: major bleeding

    Diagnosed major bleeding

    30 days

  • postoperative complications: postoperative pulmonary complications

    Diagnosed postoperative pulmonary complications

    30 days

  • postoperative complications: ECMO

    patients with ECMO

    30 days

  • postoperative complications: IABP

    patients with IABP

    30 days

  • Ventilation time

    Number of hours the patient with mechanical ventilation

    Through study completion, an average of 7 days

  • Length of ICU stay

    Number of days the patient stays in the intensive care unit

    Through study completion, an average of 30 days

Secondary Outcomes (4)

  • Total hospital costs

    Through study completion, an average of 30 days

  • ICU costs

    Through study completion, an average of 30 days

  • Length of hospital stay

    Through study completion, an average of 30 days

  • Length of postoperative hospital stay

    Through study completion, an average of 30 days

Study Arms (2)

Patients with postoperative complications

Patients with postoperative complications

Other: Patients diagnosed with postoperative complications

Patients without postoperative complications

Patients without postoperative complications

Other: Patients without postoperative complications

Interventions

Patients diagnosed with postoperative complications (Acute kidney injury, Chronic Kidney disease, Infection, Delirium, MACCE, Myocardial infarction, Postoperative pulmonary complications, major bleeding, ECMO, IABP....)

Patients with postoperative complications

Patients without postoperative complications

Patients without postoperative complications

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients who are going to have an cardiovascular operation.

You may qualify if:

  • Age more than 18 years Undergoing Cardiovascular surgery

You may not qualify if:

  • Missing primary outcomes or variables

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC

Beijing, 100037, China

RECRUITING

Study Officials

  • Yuefu Wang, MD

    China National Center for Cardiovascular Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuefu Wang, MD

CONTACT

Yuchen Gao, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

May 9, 2021

First Posted

May 13, 2021

Study Start

January 1, 2012

Primary Completion

December 31, 2021

Study Completion

December 12, 2025

Last Updated

May 14, 2021

Record last verified: 2021-05

Locations