AKI, Arrythmia, Cardiac Surgery, Hospital Length of Stay, ICU Length of Stay, Mechanical Circulatory Support, Mechanical Ventilation, Mortality, NGAL, Renal Replacement Therapy, Surgical Complication, Tracheostomy
Conditions
Keywords
The Hyperoxia trial, hyperoxia, oxygen therapy
Brief 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.
Interventions
OTHERHyperoxia 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.
OTHERNormoxia 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.
Sponsors
University of Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients randomized 1:1 to hyperoxia or normoxia during CPB
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients (\>18 years old) * need for elective cardiac surgery requiring CPB (i.e., isolated valve repair/replacement, coronary artery bypass grafting, or ascending aorta surgery) * Time frame from July 1st to September 15th 2025
Exclusion criteria
* refusal of consent, * pregnancy, * previous Intensive Care Unit (ICU) admission, * history of cardiac surgery requiring CPB, * signs of preoperative cardiogenic shock (defined as requiring inotropic support, intra-aortic balloon pump, or other mechanical circulatory assistance), * intraoperative need for circulatory arrest.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of of kidney failure in adult patients undergoing to elective cardiac surgery required CPB | At 24 hours after surgery | The renal outcomes were evaluated 24 hours after surgery, on the first postoperative day. The failure was defined according to KDIGO criteria and included estimated glomerular filtration rate (eGFR), serum Neutrophil Gelatinase-Associated Lipocalin (NGAL), and the need for postoperative renal replacement therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with NGAL > 50ng/ml (index of acute kidney injury) | At 24 hours after surgery | Serum NGAL was measured on blood sample and if NGAL: \< 50 ng/mL → normal renal function 50-150 ng/mL → possible early injury 150-200 ng/mL → suggestive of AKI 400-500 ng/mL → likely AKI / moderate to severe AKI |
| Number of renal replacement therapy after surgey | Within 24 hours postoperatively | Requirement for CRRT |
| Number of patients affected by postoperative arrhythmias | within 28 days after randomization | Postoperative arrhythmias were defined according to AHA criteria |
| Number of patients needing extracorporeal membrane support | within 28 days after randomization | Mechanical circulatory support requirement was defined as veno-venous support, veno-arterial support |
| Number of patients experienced surgical complications | within 28 days after randomization | Surgical complications were defined according to Clavien-Dindo scale |
| Number of patients needing tracheostomy | within 28 days after randomization | Tracheostomy |
Countries
Italy
Outcome results
None listed