Perioperative Outcome of Congenital Heart Disease Surgery in Childhood

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 2019

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Rate of systemic inflammatory response syndrome
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Week

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nanjing Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hong Liu, Principal Investigator – Peking Union Medical College
  • Overall Official(s)
    • Hong Liu, MD, Study Director, Peking Union Medical College
  • Overall Contact(s)
    • Hong Liu, MD, DR.HONGLIU@FOXMAIL.COM

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