Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04093011
Other study ID # TedaICH-Thousands of plans
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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.
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04992793 - Paediatric Brain Injury Following Cardiac Interventions
Recruiting NCT05213598 - Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
Completed NCT04136379 - Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
Completed NCT04814888 - 3D Airway Model for Pediatric Patients
Recruiting NCT04920643 - High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery N/A
Completed NCT05934578 - Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training N/A
Recruiting NCT06041685 - Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia N/A
Recruiting NCT05902013 - Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation N/A
Not yet recruiting NCT05687292 - Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
Not yet recruiting NCT05524324 - Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT N/A
Completed NCT02746029 - Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
Completed NCT02537392 - Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease N/A
Completed NCT03119090 - Fontan Imaging Biomarkers (FIB) Study
Recruiting NCT02258724 - Swiss National Registry of Grown up Congenital Heart Disease Patients
Terminated NCT02046135 - Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery Phase 2
Completed NCT01966237 - Milrinone Pharmacokinetics and Acute Kidney Injury
Recruiting NCT01184404 - Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery N/A
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01178710 - Effect of Simvastatin on Cardiac Function N/A