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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04093011
Enrollment
6500
Registered
2019-09-17
Start date
2012-01-01
Completion date
2019-12-31
Last updated
2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

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.

Interventions

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

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of systemic inflammatory response syndromepostoperative 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.

Countries

China

Contacts

Primary ContactHong Liu, MD
DR.HONGLIU@FOXMAIL.COM

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026