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NCT Number: NCT07510672

Hyperoxia vs Normoxia During Cardiopulmonary Bypass

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.

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Key information

Conditions

AKI Arrhythmias, Cardiac Arrythmia Cardiac Surgery Cardiovascular Diseases Heart Diseases Hospital Length of Stay Hyperoxia ICU Length of Stay Mechanical Circulatory Support Mechanical Ventilation Mortality NGAL Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Replacement Therapy Signs and Symptoms Signs and Symptoms, Respiratory Surgical Complication Tracheostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Padova University Hospital

Padova, PD, 35121, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of of kidney failure in adult patients undergoing to elective cardiac surgery required CPB

    Time frame: 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 outcomes

  1. Number of patients with NGAL > 50ng/ml (index of acute kidney injury)

    Time frame: 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

  2. Number of renal replacement therapy after surgey

    Time frame: Within 24 hours postoperatively

    Requirement for CRRT

  3. Number of patients affected by postoperative arrhythmias

    Time frame: within 28 days after randomization

    Postoperative arrhythmias were defined according to AHA criteria

  4. Number of patients needing extracorporeal membrane support

    Time frame: within 28 days after randomization

    Mechanical circulatory support requirement was defined as veno-venous support, veno-arterial support

  5. Number of patients experienced surgical complications

    Time frame: within 28 days after randomization

    Surgical complications were defined according to Clavien-Dindo scale

  6. Number of patients needing tracheostomy

    Time frame: within 28 days after randomization

    Tracheostomy

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Acronym: IPEROXIA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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