AKIIPEROXIANCT07510672
Hyperoxia vs Normoxia During Cardiopulmonary Bypass
A study testing Hyperoxia group in people with AKI and Renal Replacement Therapy, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI, Renal Replacement Therapy, NGAL
- What is being tested?
- Hyperoxia group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyperoxia During Cardiopulmonary Bypass in Adult Cardiac Surgery: A Randomized Controlled Pilot Study
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.
Read the 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
- Being tested
- Hyperoxia group, Normoxia group (control)
- Keywords
- The Hyperoxia trial, hyperoxia, oxygen therapy
- Medical subject headings
- Arrhythmias, Cardiac, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperoxia groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Normoxia group (control) |
| 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. Receives: Other: Hyperoxia group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 24 hours after surgery
Secondary outcomes (6)
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
Measured: At 24 hours after surgery
Number of renal replacement therapy after surgey
Requirement for CRRT
Measured: Within 24 hours postoperatively
Number of patients affected by postoperative arrhythmias
Postoperative arrhythmias were defined according to AHA criteria
Measured: 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
Measured: within 28 days after randomization
Number of patients experienced surgical complications
Surgical complications were defined according to Clavien-Dindo scale
Measured: within 28 days after randomization
Number of patients needing tracheostomy
Tracheostomy
Measured: within 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Jul 2025
- Primary completion15 Sep 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomized 1:1 to hyperoxia or normoxia during CPB
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annalisa Boscolo, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510672
- Sponsor's protocol ID
- HOT-CPB-01
- Acronym
- IPEROXIA
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperoxia During Cardiopulmonary Bypass in Adult Cardiac Surgery: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07510672
- Acronym / sponsor ID
- IPEROXIA / HOT-CPB-01
- Conditions
- AKI, Renal Replacement Therapy, NGAL, Arrythmia, Mechanical Ventilation, Tracheostomy
- Keywords
- The Hyperoxia trial, hyperoxia, oxygen therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients randomized 1:1 to hyperoxia or normoxia during CPB
| Arm | Type | Receives |
|---|---|---|
| Normoxia group | Sham comparator | Other: Normoxia group (control)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 | Other: Hyperoxia groupHyperoxia 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperoxia groupAfter 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 |
| 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 |
Primary outcome
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.
6 secondary outcomes
Number of patients with NGAL > 50ng/ml (index of acute kidney injury)
Time frame: At 24 hours after surgery
Number of renal replacement therapy after surgey
Time frame: Within 24 hours postoperatively
Number of patients affected by postoperative arrhythmias
Time frame: within 28 days after randomization
Number of patients needing extracorporeal membrane support
Time frame: within 28 days after randomization
Number of patients experienced surgical complications
Time frame: within 28 days after randomization
Number of patients needing tracheostomy
Time frame: within 28 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperoxia group in people with AKI and Renal Replacement Therapy, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of of kidney failure in adult patients undergoing to elective cardiac surgery required CPB (time frame: At 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.