Perioperative Outcome of Congenital Heart Disease Surgery in Childhood

Congenital Heart Disease Clinical Trial

Official title:

Perioperative Outcome of Congenital Heart Disease Surgery in Childhood: Results From a Chinese Cross-regional Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04093011
• Other study ID #: TedaICH-Thousands of plans
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: Nanjing Medical University
• Contact: Hong Liu, MD
• Email: DR.HONGLIU[@]FOXMAIL.COM
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Congenital heart disease is the most common congenital malformation in the world with high morbidity and mortality. However, there is no data to assess the perioperative outcome of congenital heart disease surgery among Chinese cross-regional population. This study aims to investigate the perioperative outcome of congenital heart disease surgery in childhood from a chinese cross-regional cohort.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6500
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Subject was aged 1 week-18 years

• Subjects underwent congenital heart disease surgery;

• Available data to investigate perioperative outcome.

Exclusion Criteria:

• Cardiac reoperation;

• Emergency surgery;

• Interventional procedure within prior 30 days prior to surgery;

• Missing outcome data.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• Congenital Heart Disease Surgery
Patients with congenital heart disease will undergo congenital heart disease surgery.

Locations

Country	Name	City	State
China	TEDA International Cardiovascular Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of systemic inflammatory response syndrome	Systemic inflammatory response syndrome was determined mainly on (i) Core temperature of >38.5°C or <36°C measured by rectal, oral, or central catheter probe; (ii) Tachycardia, defined as a mean heart rate >2 SD above normal for age in the absence of external stimulus, chronic drugs, or painful stimuli; or otherwise unexplained persistent elevation over a 0.5- to 4-hr time period, or for children <1 yr old: bradycardia, defined as a mean heart rate <10th percentile for age in the absence of external vagal stimulus; or otherwise unexplained persistent depression over a 0.5-hr time period; (iii) Mean respiratory rate >2 SD above normal for age, the prolonged mechanical ventilation defined as ventilation duration > 48 hrs, or unplanned re-intubation for an acute process not related to underlying neuromuscular disease or the receipt of general anesthesia; (iv) Leukocyte count elevated or depressed for age or >10% immature neutrophils.	postoperative day 7 or hospital discharge, whichever occurred first.