CompletedPhase 3

Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.

United States250 participantsStarted 2017-02-08

Plain-language summary

The purpose of this study is to determine whether nitric oxide is effective in the treatment of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting endothelial dysfunction undergoing prolonged cardiopulmonary bypass.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Provide written informed consent
✓. Age ≥ 18 years of age
✓. Elective cardiac or aortic surgery with CPB\>90 minutes
✓. 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).
✓. Clinical evidence of endothelial dysfunction assessed by a specifically designed questionnaire.

Exclusion criteria

✕. eGFR less than 30 ml/min/1.73 m2
✕. Emergent cardiac surgery.
✕. Life expectancy \< 1 year at the time of enrollment.
✕. Hemodynamic instability as defined by a systolic blood pressure \<90 mmHg.
✕. Mean pulmonary artery pressure ≥ 40 mm Hg and PVR \> 4 Wood Units.
✕. Left ventricular ejection fraction \< 30% by echocardiography obtained within three months of enrollment
✕. Administration of one or more Packed Red Blood Cells (RBCs) transfusion in the week prior to enrollment.
✕. X-ray contrast infusion less than 48 hours before surgery.

What they're measuring

Number of Participants With Acute Kidney Injury

Timeframe: 7 days

Trial details

NCT IDNCT02836899

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-15

Results submitted2026-01-30

View on ClinicalTrials.gov More Acute Kidney Injury trials