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CompletedNCT06578312Updated Aug 29, 2024

"Critical State" Early Warning Score After CHD Surgery and Rapid Response Team

An observational study in Congenital Heart Disease, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Completed at 1 site in China. Open to participants aged 28 Days to 14 Years. Per ClinicalTrials.gov, last updated 2024-08-29.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
4,115
Ages
28 Days to 14 Years
Sex
All
01

Study 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.

Read the detailed description

All children aged 0-14 years admitted to the PICU from 2021-2022 were enrolled continuously, and their baseline data such as gender, age, RACHS-1 score, cardiopulmonary bypass time, aortic clamping time, whether there was chromosomal lesions, whether there was preoperative endotracheal intubation/heart failure, changes in oxygenation index, lactate, and vasoactive drug scores were obtained. All variables that may lead to composite malignant events including death in the early postoperative period were included, including death, pulmonary hypertension crisis, malignant arrhythmias (supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, high-degree atrioventricular block) requiring antiarrhythmic drugs or pacemaker treatment, cardiopulmonary resuscitation, ECPR, emergency sternal expansion, severe AKI, severe ARDS, neurological complications (cerebral hemorrhage, cerebral infarction), gastrointestinal complications (gastrointestinal bleeding, intestinal obstruction, intestinal necrosis).The variables were included in the machine learning analysis to establish the model.

02

Conditions studied

  • Congenital Heart Disease

Keywords

  • congenital heart disease
  • Early warning system
  • machine learning
  • retrospective study
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 4,115 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Days to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • pediatrics admitted to ICU

Exclusion criteria

Exclusion Criteria:

  • surgery without cardiopulmonary bypass
  • neonatal
  • using extra-corporeal circulation during surgery
  • Delayed chest closing during surgery
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
4,115 participants (actual)
Patient registry
No
06

What researchers measure

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.

    Time frame: Within 48 hours after surgery

07

Study locations

1 site
  • Fuwai hospital
    Beijing, 100037, China
08

References and documents

Individual participant data

Plan to share: No — It included some private information.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06578312
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Responsible party
Xu Wang (Chief Physician, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
Aug 29, 2024
Start date
Jan 1, 2021
Primary completion
Jul 1, 2024
Completion
Jul 1, 2024
Last update
Aug 29, 2024

Study contacts

Xu Wang
principal investigator · Chinese Academy of Medical Sciences, Fuwai Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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