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Phase 3 N=250 Randomized Double-blind Prevention

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

Acute Kidney Injury

Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Number of Participants With Acute Kidney Injury — 54; 55 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Nitric Oxide (Drug); Placebo (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Aug 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Acute Kidney Injury
54; 55
SECONDARY
AKI Severity
SECONDARY
Renal Replacement Therapy
SECONDARY
Major Adverse Kidney Events (MAKE)
SECONDARY
Organ Dysfunction
SECONDARY
Prolonged Cardiovascular Support
SECONDARY
Vasoactive-inotropic Score (VIS)
SECONDARY
Duration of Mechanical Ventilation
SECONDARY
Intensive Care Unit Length of Stay (ICU-LOS)
SECONDARY
Hospital Length of Stay (LOS)

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.

Eligibility Criteria

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 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.
  • 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02836899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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