A Phase 2 interventional study of Inhaled Nitric Oxide (iNO) use in Cardiac Surgery Intensive Care Treatment, Pulmonary Hypertension and Right Ventricular (RV) Dysfunction, sponsored by Southeast University, China. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Southeast University, China · Phase 2, Interventional, and Treatment
Right ventricular (RV) dysfunction complicates 0.1-3% of cardiac surgical procedures and is strongly associated with elevated postoperative mortality. Pulmonary hypertension is a key determinant of perioperative RV failure. Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator that reduces pulmonary arterial pressure and has been widely used as adjunctive therapy in this setting. However, whether iNO influences systemic microcirculatory perfusion in these patients remains undefined.
We conducted a single-centre, prospective, interventional study. Adult patients with post-cardiotomy RV dysfunction - defined as central venous pressure (CVP) ≥ 15 mmHg combined with a pulmonary artery systolic pressure (PASP) > 35 mmHg on transthoracic echocardiography - were eligible. On top of standard postoperative care, patients received inhaled NO at 10-20 ppm for 2 hours without any concomitant change in vasoactive support. General characteristics, haemodynamic variables and sublingual microcirculatory parameters were recorded at baseline and again after 2 hours of iNO. The primary endpoint was the change in sublingual perfused vessel density (PVD). Secondary endpoints included mean arterial pressure (MAP), CVP, transthoracic echocardiographic indices, oxygenation index (OI), other sublingual microcirculatory parameters, capillary refill time (CRT), duration of mechanical ventilation and ICU length of stay.
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's enrollment of 60 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Southeast University, China is the lead sponsor of 168 studies on the registry; 45 are open to participants now.
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Exclusion criteria :
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Contraindication
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On top of standard postoperative management (including conventional mechanical ventilation, sedation, vasoactive and inotropic support, fluid management and renal replacement therapy as clinically indicated), patients received inhaled nitric oxide at a concentration of 10-20 ppm delivered through the inspiratory limb of the ventilator circuit using a validated NO delivery system with continuous monitoring of NO, NO2 and O2 concentrations.
Drug: Inhaled Nitric Oxide (iNO) use
On top of standard postoperative management (including conventional mechanical ventilation, sedation, vasoactive and inotropic support, fluid management and renal replacement therapy as clinically indicated), patients received inhaled nitric oxide at a concentration of 10-20 ppm delivered through the inspiratory limb of the ventilator circuit using a validated NO delivery system with continuous monitoring of NO, NO2 and O2 concentrations. The dose was titrated within this range by the treating intensivist according to the haemodynamic response. No changes to vasoactive, inotropic or vasopressor therapy, sedation or ventilator settings were made during the 2-hour study window unless clinically mandated, in which case the patient was withdrawn from analysis. Haemodynamic, echocardiographic and microcirculatory measurements were performed immediately before iNO initiation (0 h) and after 2 hours of continuous administration (2 h).
perfused vessel density (PVD)
Perfused vessel density (PVD) is defined as the density of small vessels with actual blood flow per unit tissue area (usually capillaries and small vessels with diameter \<20 μm), obtained noninvasively at the sublingual mucosa using a handheld vital microscope (sidestream dark field, SDF, or incident dark field, IDF) probe.
Time frame: At enrollment and 2 hours after study drug administration
Heart rate
Time frame: At enrollment and 2 hours after study drug administration
Mean arterial pressure
Time frame: At enrollment and 2 hours after study drug administration
Central venous pressure
Time frame: At enrollment and 2 hours after study drug administration
Urine output
Time frame: At enrollment and 2 hours after study drug administration
Duration of mechanical ventilation, ICU length of stay and 28-day mortality.
Time frame: At enrollment and 28 days after study drug administration
Tricuspid annular plane systolic excursion (TAPSE)
Measures the longitudinal displacement of the tricuspid annulus toward the cardiac apex during systole, obtained by M-mode in the apical 4-chamber view.
Time frame: At enrollment and 28 days after study drug administration
Right ventricular fractional area change (RVFAC)
Calculated as: (RV end-diastolic area - RV end-systolic area) / RV end-diastolic area × 100%, by tracing the RV area in the apical 4-chamber view.
Time frame: At enrollment and 28 days after study drug administration
E/e' ratio
This ratio is used to estimate left ventricular filling pressure (LVFP/LVEDP) and grade diastolic dysfunction.
Time frame: At enrollment and 2 hours after study drug administration
Pulmonary artery systolic pressure (PASP)
Noninvasively estimated from the peak tricuspid regurgitation (TR) jet velocity: PASP = 4 × (TR velocity)² + estimated right atrial pressure.
Time frame: At enrollment and 2 hours after study drug administration
PaO₂/FiO₂ ratio
Arterial oxygen partial pressure divided by the fraction of inspired oxygen
Time frame: At enrollment and 2 hours after study drug administration
Lactate
Time frame: At enrollment and 2 hours after study drug administration
Central venous-to-arterial PCO₂ difference (Pcv-aCO₂)
Reflects the adequacy of blood flow (cardiac output) to clear CO₂ produced by tissues-a "flow" marker rather than an oxygenation marker.
Time frame: At enrollment and 2 hours after study drug administration
Central venous oxygen saturation (ScvO₂)
Oxygen saturation of blood sampled from the superior vena cava (central venous catheter), reflecting the balance between systemic oxygen delivery (DO₂) and consumption (VO₂).
Time frame: At enrollment and 2 hours after study drug administration
Capillary refill time (CRT)
Time for distal capillary bed (e.g., fingertip/knee) to return to baseline color after standardized compression (5 s) - a bedside peripheral/ microcirculatory perfusion marker.
Time frame: At enrollment and 2 hours after study drug administration
microvascular flow index (MFI)
A semi-quantitative flow velocity score: the image is divided into 4 quadrants, and the predominant flow type in each quadrant is scored: 0 = no flow 1. = intermittent flow 2. = slow flow 3. = continuous normal flow The final MFI is the mean of the 4 quadrant scores;
Time frame: At enrollment and 2 hours after study drug administration
proportion of perfused vessels (PPV)
The percentage of vessels with blood flow out of all vessels: PPV = (number of perfused vessels ÷ total number of vessels) × 100%
Time frame: At enrollment and 2 hours after study drug administration
Plan to share: Yes
Supporting information: Clinical study report
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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