An interventional study of Hyperoxia group and Normoxia group (control) in AKI, Renal Replacement Therapy and NGAL, sponsored by University of Padova. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by University of Padova · Not applicable, Interventional, and Supportive care
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.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's enrollment of 104 is close to the median of 100 across 517 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →University of Padova is the lead sponsor of 215 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Normoxia group (control)
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.
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.
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 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.
Time frame: At 24 hours after surgery
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
Time frame: At 24 hours after surgery
Number of renal replacement therapy after surgey
Requirement for CRRT
Time frame: Within 24 hours postoperatively
Number of patients affected by postoperative arrhythmias
Postoperative arrhythmias were defined according to AHA criteria
Time frame: 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
Time frame: within 28 days after randomization
Number of patients experienced surgical complications
Surgical complications were defined according to Clavien-Dindo scale
Time frame: within 28 days after randomization
Number of patients needing tracheostomy
Tracheostomy
Time frame: within 28 days after randomization
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2025 to primary completion in Sep 2025, 2 months.
Of 171 non-industry interventional studies with no phase under Arrhythmias, Cardiac, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's 2 months is below that.
Counting every sponsor, half of 242 studies reached it within 24 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.