Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.
Source: ClinicalTrials.gov NCT02836899 ↗Summary
Linked Publications (2)
-
Protocol of a randomised controlled trial in cardiac surgical patients with endothelial dysfunction aimed to prevent postoperative acute kidney injury by administering nitric oxide gas.
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Nitric Oxide to Reduce Acute Kidney Injury in Patients with Preexisting Endothelial Dysfunction Requiring Prolonged Cardiopulmonary Bypass: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-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) |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT02836899) and the linked publication. 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. Informational only — not medical advice.