Reoxygenation for Cyanotic Pediatric CHD

NCT03568357 | Unknown DMC

• 1 other identifier: TedaICH-ROC
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Tetralogy of Fallot

Keywords

tetralogy of Fallot

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• low cardiac output syndrome

  up to 30 days

Study Arms (1)

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.

Procedure: Reoxygenation

Interventions

Reoxygenation PROCEDURE

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.

Reoxygenation

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, 300457, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 23804862 BACKGROUND

• 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. doi: 10.1055/s-2000-7879.

  PMID: 11100757 BACKGROUND

• Yang 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.

  PMID: 33902450 DERIVED

MeSH Terms

Conditions

Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xiaocheng Liu, MD

  TEDA International Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Liu, MD

CONTACT

8618801281613; dr.hongliu@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: December 24, 2017
• First Posted: June 26, 2018
• Study Start: January 1, 2012
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)