NCT06578312

Brief Summary

By establishing a warning scoring tool for the early \"critical state\" after congenital heart disease surgery, the multidisciplinary rapid response team is proactively activated, forming an integrated treatment model of early warning-team decision-making-organ assistance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,115

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2021

Completed
3.5 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
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

3.5 years

First QC Date

August 26, 2024

Last Update Submit

August 27, 2024

Conditions

Congenital Heart Disease

Keywords

congenital heart diseaseEarly warning systemmachine learningretrospective study

Outcome Measures

Primary Outcomes (1)

  • event occurrence-an inclusion of composite clinical diagnose

    critical status included clinical diagnose：arrhythmia（ventricular tachycardia、ventricular fibrillation、refractory supraventricular tachycardia ）,prognosis（death or live）,bedside thoracotomy,CPR,ECMO,extracorporeal circulation establishment,renal replacement therapy,peritoneal dialysis, hemofiltration. If one of the above diagnosis and treatment used in patients, they would be divided to case group.

    Within 48 hours after surgery

Eligibility Criteria

Age28 Days - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

We included pediatrics with congenital heart disease who undergone surgery in our center.They should under 14 years old.

You may qualify if:

  • pediatrics admitted to ICU

You may not qualify if:

  • surgery without cardiopulmonary bypass
  • neonatal
  • using extra-corporeal circulation during surgery
  • Delayed chest closing during surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, 100037, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Xu Wang

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

August 26, 2024

First Posted

August 29, 2024

Study Start

January 1, 2021

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

It included some private information.

Locations

CN(1)