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Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

ConditionPulmonary Hypertension Due to Left Heart Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorZagazig University

About this trial

The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled to undergo mitral valve surgery by cardiopulmonary bypass with estimated mean pulmonary artery pressure =>55 estimated by using preoperative Doppler echocardiography

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Milrinone inhalation

    Drug

    After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered

  • Milrinone infusion

    Drug

    After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Group IH(inhaled milrinone)Active comparator 1 intervention
Group B: Group Iv(Intravenous milrinone)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

mean arterial pressure

The effect of inhaled milrinone on mean arterial pressure is compared with the effect of intravenous milrinone

Time frame
change in mean arterial pressure is recorded 10 minutes after milrinone administration after induction (T1), at the end of nebulization (T2), before cardiopulmonary bypass (T3) and after cardiopulmonary bypass(T4)

Secondary outcomes

1

mean pulmonary arterial pressure

The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone

Time frame
change in mean pulmonary arterial pressure 10 minutes after milrinone administration
2

systemic vascular resistance

The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone

Time frame
change in systemic vascular resistance 10 minutes after milrinone administration
3

pulmonary vascular resistance

The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone

Time frame
change in pulmonary vascular resistance 10 minutes after milrinone administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zagazig University

Lead sponsor

Source ClinicalTrials.gov
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