Reoxygenation for Cyanotic Pediatric CHD

Tetralogy of Fallot Clinical Trial

— Reoxygenation  

Official title:

Reoxygenation Cardiopulmonary Bypass for Surgical Repair of Pediatric Cyanotic CHD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03568357
• Other study ID #: TedaICH-ROC
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2018
• Source: Nanjing Medical University
• Contact: Hong Liu, MD
• Phone: 8618801281613
• Email: dr.hongliu[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Tetralogy of Fallot

Intervention

Procedure:
• Reoxygenation
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.

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, 

References & Publications (2)

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. — View Citation

Matheis 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	up to 30 days
Secondary	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.	up to 30 days