Congenital Heart DiseaseNCT04093011
Perioperative Outcome of Congenital Heart Disease Surgery in Childhood
An observational study of Congenital Heart Disease, run by Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 week to 18 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Congenital Heart Disease Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 6,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients aged 1 week-18 years underwent congenital heart disease surgery from different Chinese regions.
Who may be able to join
- Subject was aged 1 week-18 years
- Subjects underwent congenital heart disease surgery;
- Available data to investigate perioperative outcome.
Who cannot join
- Cardiac reoperation;
- Emergency surgery;
- Interventional procedure within prior 30 days prior to surgery;
- Missing outcome data.
Trial locations and contacts
1 site in 1 country.
Hong Liu, MD contact
China1 site, 1 recruiting
- Recruiting
TEDA International Cardiovascular Hospital
Tianjin, Tianjin Municipality, 300457
Hong Liu, MD, 188012181613, dr.hongliu@foxmail.com
About this study
Official title: Perioperative Outcome of Congenital Heart Disease Surgery in Childhood: Results From a Chinese Cross-regional Cohort Study
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
- Being tested
- Congenital Heart Disease Surgery
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Congenital Heart Disease SurgeryProcedure or surgery
Patients with congenital heart disease will undergo congenital heart disease surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative day 7 or hospital discharge, whichever occurred first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 Jan 2012
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Liu, Peking Union Medical College
- Investigators
- Hong Liu, MD, Study director, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093011
- Sponsor's protocol ID
- TedaICH-Thousands of plans
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Outcome of Congenital Heart Disease Surgery in Childhood: Results From a Chinese Cross-regional Cohort Study
- ClinicalTrials.gov ID
- NCT04093011
- Acronym / sponsor ID
- TedaICH-Thousands of plans
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,500 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 week to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients aged 1 week-18 years underwent congenital heart disease surgery from different Chinese regions.
Key inclusion criteria (3 listed)
- Subject was aged 1 week-18 years
- Subjects underwent congenital heart disease surgery;
- Available data to investigate perioperative outcome.
Key exclusion criteria (4 listed)
- Cardiac reoperation;
- Emergency surgery;
- Interventional procedure within prior 30 days prior to surgery;
- Missing outcome data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Congenital Heart Disease SurgeryPatients with congenital heart disease will undergo congenital heart disease surgery. | Procedure or surgery | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Liu, MD contact
Hong Liu, MD study director
Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Liu, MD (DR.HONGLIU@FOXMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of systemic inflammatory response syndrome (time frame: postoperative day 7 or hospital discharge, whichever occurred first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.