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Clinical Trials/2025-520808-10-00
2025-520808-10-00
Not yet recruiting
Phase 3

Role of inhaled nitric oxide on right ventricular function and pulmonary vascular mechanics following cardiac surgery

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa2 sites in 1 country50 target enrollmentStarted: January 24, 2025Last updated:
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Overview

Phase
Phase 3
Status
Not yet recruiting
Enrollment
50
Locations
2
Primary Endpoint
Parameters of right ventricular function
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To study the effects of inhaled iNO on pulmonary vascular mechanics, right ventricular function, and right ventricular-vascular coupling in patients in the immediate cardiac surgery post-operative period

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Obtained informed consent
  • •Age > 18 years
  • •Under passive mechanical ventilation
  • •Pre-operative FEVI ≥ 30%
  • •Absence of hypovolemia: absence of ventricular "kissing" and / or superior vena cava collapsibility index < 20%
  • •Stable spontaneous heart rythm
  • •Post-operative hemodynamic stability

Exclusion Criteria

  • •Cor pulmonale or presence of preoperative pulmonary vascular pathology
  • •Chronic pulmonary hypertension (mPAP> 35 mmHg) related to advanced COPD or chronic thromboembolic disease
  • •Surgery involving the tricuspid or pulmonary valves
  • •Intra- or post-operative use of nitroprusside or nitroglycerine
  • •Pre-operative dependence of inotropic drugs or vasoconstrictors
  • •Use of levosimendan. If dobutamine is in use, patients can be included provided the infusion can be stopped or is ≤ 1 µg/kg/min
  • •Pacemaker dependency

Outcomes

Primary Outcomes

Parameters of right ventricular function

Parameters of right ventricular function

Secondary Outcomes

  • Results of the electrical impedance tomography (EIT): regional distribution of ventilation and perfusion and EIT pulsatility

Investigators

Sponsor Class
Laboratory/Research/Testing facility
Responsible Party
Principal Investigator
Principal Investigator

Isabel Magaña Bru

Scientific

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

Study Sites (2)

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