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Can a simple gas save lives after heart surgery? major trial launches

NCT ID NCT06702553

Disease control Sponsor: Xijing Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether giving inhaled nitric oxide during and after heart surgery can lower the risk of death or major complications like kidney failure, stroke, and heart failure. About 3,650 adults having elective heart surgery with a heart-lung machine will receive either nitric oxide or a placebo gas. The goal is to see if this treatment reduces the need for intensive life support within 30 days after surgery.

What this could mean

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

Active substance
inhaled nitric oxide gas
What this could lead to
If it works, this could become a standard treatment to prevent life-threatening complications like kidney failure, stroke, or heart failure after heart surgery.
What could go wrong
Earlier smaller studies showed benefits in lab tests but not in survival or recovery. This large trial aims to confirm if those benefits are real, but it may still fail to improve hard 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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 3,650 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Mar 2029

An estimate. End dates often move.

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: 1. Age ≥18 years. 2. Elective cardiac or aortic surgery requiring CPB 3. Without history of previous open heart surgery. Exclusion Criteria: 1. Immediate emergency cardiac surgery; 2. Cardiac surgery that requires deep hypothermic circulatory arrest; 3. Planned cardiac surgery for congenital heart disease repair; 4. Planned for heart transplatation 5. Ongoing heart failure or low output syndrome already on intensive support (IABP, ECMO, left ventricular assist device such as impella, mechanical ventilation), left ventricular ejection fraction of \< 30% or comparable, equivalent preoperative conditions 6. Already accepted or currently on inhaled NO therapy or inhaled/aerosolized prostacyclin in the week prior to the enrollment; 7. Endstage kidney disease with estimated glomerular filtration rate (eGFR) \< 15 ml/min or already on renal replacement surgery. 8. Hemophilia A or B 9. Other terminal stage of chronic disease with life expectancy less than 1 year per evaluation and adjudication of the attending physicians.

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As listed by the trial registrant

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

Adult patients undergoing cardiovascular surgery with cardiopulmonary bypass Cardiac surgery Cardiopulmonary bypass Nitric oxide

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cardiology Research Institute, Tomsk National Research Medical Center

    NOT_YET_RECRUITING

    Tomsk, 634012, Russia

  • Massachusetts General Hospital, Department of Anesthesia, Critical Care and Pain Medicine

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Xijing Hospital

    RECRUITING

    Xi'an, Shaanxi, 710032, China

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