Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normoxia group | Sham Comparator | 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. |
|
| Hyperoxia group | Experimental | Hyperoxia group (intervention): 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperoxia group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of of kidney failure in adult patients undergoing to elective cardiac surgery required CPB | 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. | At 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with NGAL > 50ng/ml (index of acute kidney injury) | 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 | At 24 hours after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Padova University Hospital | Padova | PD | 35121 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients randomized 1:1 to hyperoxia or normoxia during CPB
Not provided
Not provided
Not provided
Not provided
| Normoxia group (control) | Other | 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. |
|
| Number of renal replacement therapy after surgey |
Requirement for CRRT |
| Within 24 hours postoperatively |
| Number of patients affected by postoperative arrhythmias | Postoperative arrhythmias were defined according to AHA criteria | within 28 days after randomization |
| Number of patients needing extracorporeal membrane support | Mechanical circulatory support requirement was defined as veno-venous support, veno-arterial support | within 28 days after randomization |
| Number of patients experienced surgical complications | Surgical complications were defined according to Clavien-Dindo scale | within 28 days after randomization |
| Number of patients needing tracheostomy | Tracheostomy | within 28 days after randomization |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D018496 | Hyperoxia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
Not provided
Not provided