Tetralogy of FallotReoxygenationNCT03568357
Reoxygenation for Cyanotic Pediatric CHD
An observational study of Tetralogy of Fallot, run by Nanjing Medical University at 1 site in China.
Trial summary
Evidence is emerging that those patients with cyanotic pathologies may be more vulnerable to end-organ injury during and after surgery than those patients without, because of compromised cardiopulmonary performances or the proinflammatory state that follows conventional hyperoxic cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Tetralogy of Fallot
- What is being tested?
- Reoxygenation
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 31 Dec 2018
- 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 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The infants and young children aged 1 months to 18 years were eligible for enrolment in this study if they had echocardiography confirmed congenital heart diseases.
Who may be able to join
- The operation-naive infants and young children aged 1 months to 18 years old were eligible for enrolment if they were indicated for undergoing anticipated radical repair of cyanotic congenital heart disease with cardiopulmonary bypass.
Who cannot join
- The chromosomal defects, airway and parenchymal lung disease, immunodeficiency, blood transfusion during the current admission, previous cardiac operation, or the opinion of the treating physician that randomization would not be in the best interest of the patient (lack of equipoise)
Trial locations and contacts
1 site in 1 country.
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: Reoxygenation Cardiopulmonary Bypass for Surgical Repair of Pediatric Cyanotic CHD
Evidence is emerging that those patients with cyanotic pathologies may be more vulnerable to end-organ injury during and after surgery than those patients without, because of compromised cardiopulmonary performances or the proinflammatory state that follows conventional hyperoxic cardiopulmonary bypass.
Several clinical and basic studies have identified that controlled oxygenation during the initiation of bypass significantly improved the cardiac adaptation and remodeling capacity than hyperoxic oxygenation strategy among cyanotic patients undergoing tetralogy of Fallot repair, as evidenced by these reduced myocardial gene expression profiles associated with reoxygenation injury.
The investigators designed the reoxygenation for pediatric cardiac surgery study to investigate the effect of reoxygenation during cardiopulmonary bypass on clinical outcomes in patients with cyanotic congenital heart disease .
- Conditions
- Tetralogy of Fallot
- Being tested
- Reoxygenation
- Keywords
- tetralogy of Fallot
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReoxygenationProcedure or surgery
After one minute of full bypass, fraction of inspired oxygen (FiO2) in conservative group was increased at increments of 0.1 per minute to reach an FiO2 target of 40% that was adjusted to maintain an arterial PO2 in the range of 250 mm Hg or less during the bypass, while FiO2 in liberal group was increased at increments of 0.1 per minute to reach a FiO2 target of 80% adjusted to maintain PO2 in the range of 300 mm Hg or more, on the basis of arterial PO2 level measured via a point of care blood gas analyzer.
| Study group | Role | What they receive |
|---|---|---|
| Reoxygenation | After one minute of full bypass, fraction of inspired oxygen (FiO2) in liberal group was increased at increments of 0.1 per minute to reach a FiO2 target of 40%-80% adjusted reoxygenation to maintain PO2 in the range of 250mm Hg-300 mm Hg or more during the bypass. Receives: Procedure: Reoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Logistic Organ Dysfunction (PELOD-2) score
the change in the updated Pediatric Logistic Organ Dysfunction (PELOD-2) score (PELOD-2 score; range, 0 to 33 points, with higher scores indicating more severe organ dysfunction)
Measured: up to 30 days
Secondary outcomes (1)
low cardiac output syndrome
Low cardiac output syndrome was defined as cardiac index < 2.2 L/min/m2 of BSA with central venous pressure >18 mmHg and mean arterial pressure < 50 mmHg.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Jan 2012
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 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
- Xiaocheng Liu, MD, Principal investigator, TEDA International Cardiovascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568357
- Sponsor's protocol ID
- TedaICH-ROC
- Acronym
- Reoxygenation
- Status last verified
- Jun 2018
- First submitted
- 24 Dec 2017
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Babu B, Bhat S, Prabuswamy HP, Kamalapurkar G, Kumar HV, Libu GK, Shilpa S, Lokesh BK. Controlling oxygenation during initiation of cardiopulmonary bypass: can it improve immediate postoperative outcomes in cyanotic children undergoing cardiac surgery? A prospective randomized study. World J Pediatr Congenit Heart Surg. 2012 Jul 1;3(3):310-6. doi: 10.1177/2150135111431843.
PubMed 23804862Matheis G, Abdel-Rahman U, Braun S, Wimmer-Greinecker G, Esmaili A, Seitz U, Bastanier CK, Moritz A, Hofstetter R. Uncontrolled reoxygenation by initiating cardiopulmonary bypass is associated with higher protein S100 in cyanotic versus acyanotic patients. Thorac Cardiovasc Surg. 2000 Oct;48(5):263-8. doi: 10.1055/s-2000-7879.
PubMed 11100757Yang JN, Zhang XM, Ma LY, Lu ZJ, Zheng SQ, Hamzah AW, Shao YF, Liu H, Liu GL. Effect of cardiopulmonary bypass reoxygenation on myocardial dysfunction following pediatric tetralogy of Fallot repair. BMC Cardiovasc Disord. 2021 Apr 26;21(1):210. doi: 10.1186/s12872-021-02033-2.
PubMed 33902450
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reoxygenation Cardiopulmonary Bypass for Surgical Repair of Pediatric Cyanotic CHD
- ClinicalTrials.gov ID
- NCT03568357
- Acronym / sponsor ID
- Reoxygenation / TedaICH-ROC
- Conditions
- Tetralogy of Fallot
- Keywords
- tetralogy of Fallot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 26 Jun 2018 (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.
Evidence is emerging that those patients with cyanotic pathologies may be more vulnerable to end-organ injury during and after surgery than those patients without, because of compromised cardiopulmonary performances or the proinflammatory state that follows conventional hyperoxic cardiopulmonary bypass.
Several clinical and basic studies have identified that controlled oxygenation during the initiation of bypass significantly improved the cardiac adaptation and remodeling capacity than hyperoxic oxygenation strategy among cyanotic patients undergoing tetralogy of Fallot repair, as evidenced by these reduced myocardial gene expression profiles associated with reoxygenation injury.
The investigators designed the reoxygenation for pediatric cardiac surgery study to investigate the effect of reoxygenation during cardiopulmonary bypass on clinical outcomes in patients with cyanotic congenital heart disease .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reoxygenation | – | Procedure: ReoxygenationAfter one minute of full bypass, fraction of inspired oxygen (FiO2) in liberal group was increased at increments of 0.1 per minute to reach a FiO2 target of 40%-80% adjusted reoxygenation to maintain PO2 in the range of 250mm Hg-300 mm Hg or more during the bypass. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The infants and young children aged 1 months to 18 years were eligible for enrolment in this study if they had echocardiography confirmed congenital heart diseases.
Key inclusion criteria (1 listed)
- The operation-naive infants and young children aged 1 months to 18 years old were eligible for enrolment if they were indicated for undergoing anticipated radical repair of cyanotic congenital heart disease with cardiopulmonary bypass.
Key exclusion criteria (1 listed)
- The chromosomal defects, airway and parenchymal lung disease, immunodeficiency, blood transfusion during the current admission, previous cardiac operation, or the opinion of the treating physician that randomization would not be in the best interest of the patient (lack of equipoise)
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 |
|---|---|---|
| ReoxygenationAfter one minute of full bypass, fraction of inspired oxygen (FiO2) in conservative group was increased at increments of 0.1 per minute to reach an FiO2 target of 40% that was adjusted to maintain an arterial PO2 in the range of 250 mm Hg or less during the bypass, while FiO2 in liberal group was increased at increments of 0.1 per minute to reach a FiO2 target of 80% adjusted to maintain PO2 in the range of 300 mm Hg or more, on the basis of arterial PO2 level measured via a point of care blood gas analyzer. | Procedure or surgery | Reoxygenation |
Primary outcome
Pediatric Logistic Organ Dysfunction (PELOD-2) score
Time frame: up to 30 days
the change in the updated Pediatric Logistic Organ Dysfunction (PELOD-2) score (PELOD-2 score; range, 0 to 33 points, with higher scores indicating more severe organ dysfunction)
1 secondary outcome
low cardiac output syndrome
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 23804862Babu B, Bhat S, Prabuswamy HP, Kamalapurkar G, Kumar HV, Libu GK, Shilpa S, Lokesh BK. Controlling oxygenation during initiation of cardiopulmonary bypass: can it improve immediate postoperative outcomes in cyanotic children undergoing cardiac surgery? A prospective randomized study. World J Pediatr Congenit Heart Surg. 2012 Jul 1;3(3):310-6. doi: 10.1177/2150135111431843.
- Background: PubMed 11100757Matheis G, Abdel-Rahman U, Braun S, Wimmer-Greinecker G, Esmaili A, Seitz U, Bastanier CK, Moritz A, Hofstetter R. Uncontrolled reoxygenation by initiating cardiopulmonary bypass is associated with higher protein S100 in cyanotic versus acyanotic patients. Thorac Cardiovasc Surg. 2000 Oct;48(5):263-8. doi: 10.1055/s-2000-7879.
- Derived from this study: PubMed 33902450Yang JN, Zhang XM, Ma LY, Lu ZJ, Zheng SQ, Hamzah AW, Shao YF, Liu H, Liu GL. Effect of cardiopulmonary bypass reoxygenation on myocardial dysfunction following pediatric tetralogy of Fallot repair. BMC Cardiovasc Disord. 2021 Apr 26;21(1):210. doi: 10.1186/s12872-021-02033-2.
- Individual participant dataSharing planned: No
Related trials for Tetralogy of Fallot
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Tetralogy of Fallot (TOF), Congenital Heart Defects
Active, not recruitingObservational study
ALTERRA Post-Approval Study
Pulmonary Valve Insufficiency, Complex Congenital Heart Defect
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.
Xiaocheng Liu, MD principal investigator
TEDA International Cardiovascular Hospital
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 Tetralogy of Fallot, 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 1 inclusion and 1 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 26 Jun 2018. 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 (8618801281613, dr.hongliu@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Logistic Organ Dysfunction (PELOD-2) score (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03568357, which also lists 3 linked publications.
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 26 Jun 2018.