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A multicenter randomized controlled study of the effects of normoxic perfusion on major organ function in neonates and cyanotic CCHD infants after cardiac surgery

A multicenter randomized controlled study of the effects of normoxic perfusion on major organ function in neonates and cyanotic CCHD infants after cardiac surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109402
Enrollment
Unknown
Registered
2025-09-17
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex congenital heart disease

Interventions

Normal oxygen perfusion group:Maintain the partial pressure of oxygen within the range of 60-120 mmHg during extracorporeal circulation.
High oxygen perfusion group:Maintaining the oxygen partial pressure within the range of PaO2: 200 - 300 mmHg during extracorporeal circulation.

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1) Infants within one year of age, including full-term neonates and infants; 2) Diagnosed with cyanotic congenital heart disease (CCHD), including conditions such as tetralogy of Fallot, transposition of the great arteries, pulmonary stenosis, single ventricle, coarctation of the aorta, etc.; 3) Weighing more than 2500 grams; 4) Undergoing elective or limited cardiac surgery; 5) First surgical procedure; 6) Informed consent signed by family members.

Exclusion criteria

Exclusion criteria: 1) Gestational age at birth is less than 33 weeks; 2) Undergone emergency surgery; 3) Participated in other clinical trials; 4) Accompanied by severe complications; 5) Presence of evident systemic infection or inflammation prior to surgery; 6) Patients or their legal guardians are unable to participate in follow-up.

Design outcomes

Primary

MeasureTime frame
Perioperative incidence of major adverse events;Incidence of cardiac insufficiency;

Secondary

MeasureTime frame
Incidence of delayed chest closure;Leakage syndrome incidence;Incidence of acute lung injury;Incidence of acute liver injury;Incidence of acute kidney injury;Cardiac arrest;Mechanical Circulation Support (ECMO);Postoperative hospital stay;In-hospital mortality;Total postoperative fluid intake and outflow;ICU ventilator tube time;ICU retention time;Six-month readmission rate;1-year mortality;

Countries

China

Contacts

Public ContactZhao Ju

Beijing Anzhen Hospital, Capital Medical University

zhaojucpb@163.com+86 136 2125 2896

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026