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Treatment of Pulmonary Hypertension in High-risk Cardiac Surgery Patients Using Inhalational and Intravenous Agents (levos-milr)

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ClinicalTrials.gov Identifier: NCT04718350
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Kassiani Theodoraki, Aretaieion University Hospital

Brief Summary:
The aim of this study is to examine and compare the effect of Levosimendan and Milrinone administered intravenously and via inhalation respectively in cardiac surgery patients with pulmonary hypertension and right ventricular dysfunction.

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Cardiac Failure Pulmonary Vascular Resistance Abnormality Drug: levosimendan at a dose of 6 mcg/kg Drug: milrinone at a dose of 50 mcg/kg Not Applicable

Detailed Description:

Pulmonary hypertension (PH) is a pathophysiological disorder hemodynamically characterized by increased pulmonary vascular resistance and pressure. This can lead to right ventricle pressure overload and failure, which is worsened by cardiopulmonary bypass (CPB) and extracorporeal circulation and is accompanied by high rates of morbidity and mortality in cardiac surgery patients. Pharmacological agents used to decrease pulmonary vascular resistance and right ventricle afterload are prostaglandins, iloprost, milrinone, nitric oxide (NO) and recently Levosimendan. These agents can be administered intravenously or via inhalation.

In this study, the intravenous administration of Levosimendan will be compared with the inhalational use of milrinone in patients with pulmonary hypertension undergoing cardiac surgery.

In this setting, 40 patients with PH caused by left sided heart disease, will be assigned into two groups:

GROUP A: Intravenous administration of Levosimendan in dosage 6mcg/kg after induction of anesthesia.

GROUP B: Inhalational administration of milrinone in dosage 50mcg/kg after induction of anesthesia.

Before and after the administration of the drug, heart function will be evaluated by hemodynamic measurements obtained by the Swan-Ganz catheter. These parameters will be heart rate (HR), blood pressure (BP), mean pulmonary arterial pressure (MPAP), central venous pressure (CVP), cardiac output (CO), pulmonary capillary wedge pressure (PCWP), cardiac index (CI), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR). Transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE) will also be used.

This study will lead to conclusions regarding the effectiveness of intravenous administration of Levosimendan and inhalational use of Milrinone in the treatment of right heart failure and PH in cardiac surgery patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Intravenous Levosimendan and Inhalational Milrinone in High Risk Cardiac Patients With Pulmonary Hypertension
Actual Study Start Date : January 27, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intravenous administration of Levosimendan at a dosage of 6 mcg/kg after induction of anesthesia
in this group, 6 mcg/kg of levosimendan will be administered intravenously after anesthesia induction, aiming at prevention of pulmonary hypertension post bypass
Drug: levosimendan at a dose of 6 mcg/kg
levosimendan will be administered intravenously at a dose of 6 mcg/kg after anesthesia induction
Other Name: Group Levo

Active Comparator: Inhalational administration of Milrinone at a dosage of 50 mcg/kg after induction of anesthesia
in this group, 50 mcg/kg of milrinone will be administered via inhalation after anesthesia induction, aiming at prevention of pulmonary hypertension post bypass
Drug: milrinone at a dose of 50 mcg/kg
milrinone will be administered via inhalation at a dose of 50 mcg/kg after anesthesia induction
Other Name: Group Milri




Primary Outcome Measures :
  1. change from baseline in mean pulmonary arterial pressure (MPAP) [ Time Frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission ]
    a Swan-Ganz catheter will be used for hemodynamic measurements

  2. change from baseline in pulmonary vascular resistance (PVR) [ Time Frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission ]
    a Swan-Ganz catheter will be used for hemodynamic measurements

  3. change from baseline in mean arterial pressure (MAP) [ Time Frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission ]
    a Swan-Ganz catheter will be used for hemodynamic measurements

  4. change from baseline in systemic vascular resistance (SVR) [ Time Frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission ]
    a Swan-Ganz catheter will be used for hemodynamic measurements

  5. change from baseline in pulmonary capillary wedge pressure (PCWP) [ Time Frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission ]
    a Swan-Ganz catheter will be used for hemodynamic measurements

  6. change from baseline in cardiac output (CO) [ Time Frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission ]
    a Swan-Ganz catheter will be used for hemodynamic measurements

  7. change from baseline in tricuspid annular plane systolic excursion (TAPSE) [ Time Frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission ]
    transthoracic and transesophageal echocardiography will be used for echocardiographic measurements

  8. change from baseline in fractional area change [ Time Frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission ]
    transthoracic and transesophageal echocardiography will be used for echocardiographic measurements

  9. length of ICU stay [ Time Frame: postoperatively, an average period of 7-10 days ]
    duration of patient stay in ICU in days

  10. hospitalization time [ Time Frame: postoperatively, up to 20 days after the operation ]
    duration of hospital stay after surgery in days



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with pulmonary hypertension due to left ventricular dysfunction based on echocardiographic diagnosis preoperatively
  • elective cardiac surgery

Exclusion Criteria:

  • primary pulmonary hypertension
  • thromboembolic disease
  • chronic obstructive pulmonary disease
  • emergency surgery
  • redo surgery
  • inability to consent to the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04718350


Contacts
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Contact: Kassiani Theodoraki, PhD, DESA +306974634162 ktheodoraki@hotmail.com

Locations
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Greece
Onassis Cardiac Surgery Center Recruiting
Athens, Greece, 17674
Contact: Theophani Antoniou, MD, PhD       antoniou_fani@yahoo.gr   
Contact: Panagiotis Ftikos, MD       pftikos@yahoo.gr   
Sponsors and Collaborators
Aretaieion University Hospital
Investigators
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Principal Investigator: Kassiani Theodoraki, PhD, DESA Aretaieion University Hospital
Publications:
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Responsible Party: Dr Kassiani Theodoraki, Professor of Anesthesiology, Aretaieion University Hospital
ClinicalTrials.gov Identifier: NCT04718350    
Other Study ID Numbers: levo-milri
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Kassiani Theodoraki, Aretaieion University Hospital:
pulmonary vascular resistance
pulmonary hypertension
vasodilators
milrinone
levosimendan
cardiopulmonary bypass
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Heart Failure
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases
Simendan
Milrinone
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors