NCT07510672

Hyperoxia vs Normoxia During Cardiopulmonary Bypass

Hyperoxia During Cardiopulmonary Bypass in Adult Cardiac Surgery: A Randomized Controlled Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single-center randomized controlled pilot trial evaluates the effects of intraoperative hyperoxia compared with normoxia during cardiopulmonary bypass (CPB) in adult patients undergoing elective cardiac surgery. The primary aim is to assess the impact on postoperative renal function. Secondary outcomes include inflammatory markers, cardiovascular and pulmonary complications, resource utilization, and short-term mortality.

Detailed description

This monocentric randomized controlled pilot trial enrolled adult patients undergoing elective cardiac surgery requiring CPB. Participants were randomized (1:1) to receive either normoxic (PaO₂ 70-150 mmHg) or hyperoxic (PaO₂ \>300 mmHg) oxygenation strategies intraoperatively. The study evaluates postoperative renal function using eGFR, NGAL, renal replacement therapy, and KDIGO classification. Secondary outcomes include IL-6 levels, arrhythmias, mechanical circulatory support, surgical complications, ventilation duration, ICU/hospital stay, and 28-day mortality.

Conditions

• AKI
• Renal Replacement Therapy
• NGAL
• Arrythmia
• Mechanical Ventilation
• Tracheostomy
• Mechanical Circulatory Support
• ICU Length of Stay
• Hospital Length of Stay
• Mortality
• Surgical Complication
• Cardiac Surgery

Interventions

Type	Name	Description
OTHER	Hyperoxia group	After endotracheal intubation, FiO₂ was maintained at 0.8 and subsequently adjusted to achieve PaO₂ above 300 mmHg. During CPB, air and oxygen flows through the oxygenator were titrated to maintain a target PaO₂ greater than 300 mmHg.
OTHER	Normoxia group (control)	After endotracheal intubation, FiO₂ was initially set to 0.3 and subsequently adjusted to maintain PaO₂ between 70 and 150 mmHg. During CPB, air and oxygen flows through the oxygenator were titrated to maintain a target PaO₂ between 70 and 150 mmHg.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-09-15
• Completion: 2025-10-15
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Italy