Inhaled Milrinone Use in Patients Receiving HeartMate II LVAD: A Pilot Study

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 5, 2012

Primary Completion Date

February 1, 2013

Study Completion Date

February 21, 2014

Conditions
End Stage Heart DiseaseRight Ventricular Dysfunction
Interventions
DRUG

Inhaled, nebulized, Milrinone

1 mg/ml milrinone (dissolved in dextrose) and diluted in 0.9% normal saline in a 1:1 ratio to final drug concentration of 0.5mg/ml will be delivered via an IV pump at a fixed dose of 12 ml/hour which will run into a vibrating mesh nebulizer reservoir, connected to the mechanical ventilator circuit. Inhaled milrinone will begin at time of resumption of mechanical ventilation when initiating wean from cardiopulmonary bypass after LVAD implantation in the operating room, and run continuously for a total maximum duration of 24 hours OR until the patient is extubated whichever occurs first. Plasma milrinone levels will be assessed to determine if systemic milrinone absorption occurs after prolonged milrinone inhalation.

DRUG

inhaled nebulized milrinone

0.5 mg/ml inhaled nebulized milrinone deliver at 12 ml/hr continuously until either 24 hours or extubated.

Trial Locations (1)

68198-2265

University of Nebraska Medical Center, Omaha

All Listed Sponsors
lead

University of Nebraska

OTHER

collaborator

Thoratec Corporation

INDUSTRY

NCT01571037 - Inhaled Milrinone Use in Patients Receiving HeartMate II LVAD: A Pilot Study | Biotech Hunter | Biotech Hunter