Perioperative Outcome of Congenital Heart Disease Surgery in Childhood

NCT04093011 | Unknown DMC

• 1 other identifier: TedaICH-Thousands of plans
• Study Type: observational
• Target: 6,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Congenital Heart Disease Surgery PROCEDURE

Patients with congenital heart disease will undergo congenital heart disease surgery.

Eligibility Criteria

• Age: 1 Week - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Subject was aged 1 week-18 years
• Subjects underwent congenital heart disease surgery;
• Available data to investigate perioperative outcome.

You may not qualify if:

• Cardiac reoperation;
• Emergency surgery;
• Interventional procedure within prior 30 days prior to surgery;
• Missing outcome data.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, 300457, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hong Liu, MD

  Peking Union Medical College

  STUDY DIRECTOR

Central Study Contacts

Hong Liu, MD

CONTACT

DR.HONGLIU@FOXMAIL.COM

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 17, 2019
• Study Start: January 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

CN (1)