---
title: Perioperative Outcome of Congenital Heart Disease Surgery in Childhood
nct_id: NCT04093011
overall_status: UNKNOWN
sponsor: Nanjing Medical University
study_type: OBSERVATIONAL
primary_condition: Congenital Heart Disease
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04093011.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04093011"
ct_last_update_post_date: 2019-09-19
last_seen_at: "2026-05-12T06:33:59.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Perioperative Outcome of Congenital Heart Disease Surgery in Childhood

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

**NCT ID:** [NCT04093011](https://clinicaltrials.gov/study/NCT04093011)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 6500
- **Lead Sponsor:** Nanjing Medical University
- **Conditions:** Congenital Heart Disease
- **Start Date:** 2012-01-01
- **Completion Date:** 2019-12
- **CT.gov Last Update:** 2019-09-19

## 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.

## Eligibility

- **Minimum age:** 1 Week
- **Maximum age:** 18 Years
- **Sex:** ALL
- **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.
```

## Interventions

- **Congenital Heart Disease Surgery** (PROCEDURE) — Patients with congenital heart disease will undergo congenital heart disease surgery.

## Primary Outcomes

- **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.

## Locations (1)

- TEDA International Cardiovascular Hospital, Tianjin, Tianjin Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.teda international cardiovascular hospital|tianjin|tianjin municipality|china` — added _(2026-05-12)_

---

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