Perioperative Outcome of Congenital Heart Disease Surgery in Childhood

• Conditions: Congenital Heart Disease

• Registration Number: NCT04093011
• Lead Sponsor: Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-17
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of systemic inflammatory response syndrome	postoperative day 7 or hospital discharge, whichever occurred first.	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.

Trial Locations

Locations (1)

TEDA International Cardiovascular Hospital; 🇨🇳 Tianjin, Tianjin, China