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Gas therapy may shield kidneys during heart surgery

NCT ID NCT02836899

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether breathing in nitric oxide during and after heart surgery can prevent acute kidney injury. It included 250 adults with signs of blood vessel problems who were having long heart surgeries. Patients received either nitric oxide gas or a placebo (nitrogen) during their procedure. The goal was to see if the treatment reduced kidney damage and the need for dialysis.

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
What this could lead to
If it works, this could provide a way to prevent kidney damage after heart surgery, reducing the need for dialysis.
What could go wrong
This trial is completed, but results may not apply to all patients. The benefit may be small or limited to those with specific risk factors.

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

250 people

The number who actually took part.

Started

Feb 2017

Finished

Aug 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: 1. Provide written informed consent 2. Age ≥ 18 years of age 3. Elective cardiac or aortic surgery with CPB\>90 minutes 4. Stable pre-operative renal function without evidence of plasma creatinine level increase of ≥ 0.3 mg/dL over the prior 3 months and without renal replacement therapy (RRT). 5. Clinical evidence of endothelial dysfunction assessed by a specifically designed questionnaire. Exclusion Criteria: 1. eGFR less than 30 ml/min/1.73 m2 2. Emergent cardiac surgery. 3. Life expectancy \< 1 year at the time of enrollment. 4. Hemodynamic instability as defined by a systolic blood pressure \<90 mmHg. 5. Mean pulmonary artery pressure ≥ 40 mm Hg and PVR \> 4 Wood Units. 6. Left ventricular ejection fraction \< 30% by echocardiography obtained within three months of enrollment 7. Administration of one or more Packed Red Blood Cells (RBCs) transfusion in the week prior to enrollment. 8. X-ray contrast infusion less than 48 hours before surgery. 9. Evidence of intravascular or extravascular hemolysis from any other origin: i. Intravascular: Intrinsic RBCs defects leading to hemolytic anemia (eg, enzyme deficiencies, hemoglobinopathies, membrane defects). Extrinsic: liver disease, hypersplenism, infections (eg, bartonella, babesia, malaria), treatment with oxidizing exogenous agents (eg, dapsone, nitrites, aniline dyes), exposure to other hemolytic agents (eg, lead, snake and spider bites), lymphocyte leukemia, autoimmune hemolytic disorders. ii. Extravascular: Infection (eg, clostridial sepsis, severe malaria), paroxysmal cold hemoglobinuria, cold agglutinin disease, paroxysmal nocturnal hemoglobinuria, iv infusion of Rho(D) immune globulin, iv infusion of hypotonic solutions.

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Conditions

The condition(s) this trial relates to.

acute kidney injury

As listed by the trial registrant

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

Acute kidney injury

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.