Perioperative Outcome of Congenital Heart Disease Surgery in Childhood

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

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.

Study Overview

• Status: Unknown
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Procedure: Congenital Heart Disease Surgery

• Study Type: Observational
• Enrollment (Anticipated): 6500

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300457
      • Recruiting
      • Teda International Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients aged 1 week-18 years underwent congenital heart disease surgery from different Chinese regions.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Investigators: Study Director: Hong Liu, MD, Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: TedaICH-Thousands of plans

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No