Clinical trial • Phase III • Cardiology

Nitric oxide for Post-operative period following cardiac surgery

Phase III trial of Nitric oxide for Post-operative period following cardiac surgery. 50 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Post-operative period following cardiac surgery
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
24-01-2025
First CTIS Authorization Date
24-01-2025

Trial design

Phase III trial across 2 sites in Spain.

Target Sample Size
50

Eligibility

Recruits 50 No vulnerable populations selected. Informed consent is required ("Obtained informed consent" listed as an inclusion criterion). A subject information and informed consent form document is available. No assent process for minors is specified..

Vulnerable Population
No vulnerable populations selected. Informed consent is required ("Obtained informed consent" listed as an inclusion criterion). A subject information and informed consent form document is available. No assent process for minors is specified.

Inclusion criteria

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

Exclusion criteria

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

Endpoints

Primary endpoints

  • {"endpoint_text":"- Parameters of right ventricular function","definition_or_measurement_approach":"Evaluated by transesophageal echocardiogram (as indicated in endpoint translation)."}

Secondary endpoints

  • {"endpoint_text":"- Results of the electrical impedance tomography (EIT): regional distribution of ventilation and perfusion and EIT pulsatility","definition_or_measurement_approach":"Measured with electrical impedance tomography (EIT): regional distribution of ventilation and perfusion and EIT pulsatility."}

Recruitment

Planned Sample Size
50
Recruitment Window Months
35
Consent Approach
Informed consent is required from participants ('Obtained informed consent' is an inclusion criterion). A subject information and informed consent form document is listed (HIP RONIN-CCV_2_04_2023). No age-specific assent procedures or available languages for consent are specified in the record.

Geography

Total Number Of Sites
2
Total Number Of Participants
50

Spain

Earliest CTIS Part Ii Submission Date
24-01-2025
Latest Decision Or Authorization Date
24-01-2025
Processing Time Days
0
Number Of Sites
2
Number Of Participants
50

Sites

Site Name
Hospital Universitario De La Princesa
Department Name
Intensive Medicine Department
Contact Person Name
Fernando Suarez Sipmann
Contact Person Email
fsuarez@salud.madrid.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Intensive Medicine Department
Contact Person Name
Ricard Ferrer Roca
Contact Person Email
fsuarez@salud.madrid.org

Sponsor

Primary sponsor

Full Name
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
VasoKINOX 800 ppm mol/mol, gas comprimido medicinal
Active Substance
Nitric oxide
Modality
Small molecule
Routes Of Administration
Inhalation (gas)
Route
INHALATION GAS
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
40 PPM

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