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Does extra oxygen during heart surgery protect kidneys? new pilot study investigates.

NCT ID NCT07510672

Knowledge-focused Sponsor: University of Padova Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study looked at whether giving extra oxygen during heart surgery (when a heart-lung machine is used) affects kidney function afterward. 104 adults having elective heart surgery were randomly assigned to receive either high or normal oxygen levels. The main goal was to see if extra oxygen could reduce kidney problems. The study is complete, but because it's a small pilot, the results are not definitive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
extra oxygen (hyperoxia)
What this could lead to
If it works, this could point toward safer oxygen levels during heart surgery to protect the kidneys.
What could go wrong
This is a small pilot study, so results may not be conclusive. The approach is still experimental and may not improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

104 people

The number who actually took part.

Started

Jul 2025

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute kidney injury Arrhythmias, Cardiac cardiac rhythm disease Hyperoxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

Contacts and locations

Locations

  • Padova University Hospital

    Padova, PD, 35121, Italy

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