Acute cardiorespiratory deterioration in preterm neonates 6-12 hours after open arterial duct ligation that is called post ligation cardiac syndrome (PLCS).
Conditions
Interventions
Trade Name: Primacor, Corotrope
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MILRINONE
CAS Number: 78415-72-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Department of Anaesthesiology and Intensive Care, University of Tartu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Neonates and infants up to 90 days of age 2) Haemodynamically significant PDA requiring surgical ligation 3) Arterial catheter and/or central venous catheter in place on clinical indication 4) Informed consent given by the parents or guardians Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Renal failure requiring renal replacement therapy (peritoneal dialysis) or serum creatinine >100 µmol/l or oliguria <0.5 ml/kg/min within 6 hours 2) Hypersensitivity to milrinone or any other component of the study drug 3) Situation where the treating physician considers milrinone to be contraindicated 4) Major congenital malformation 5) Known metabolic disease 6) Informed consent from parents or guardians not obtained 7) Critically unstable state of the patient, likely fatal within 72 hours 8) The patient is already recruited in another clinical trial investigating a medical product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the pharmacokinetics and pharmacodynamics of milrinone in premature neonates after patent arterial duct surgical ligation. ;Secondary Objective: To assess the safety profile of milrinone in preterm neonates, treated for post ligation cardiac syndrome.;Primary end point(s): The pharmacokinetics of milrinone in neonates and infants up to 90 days of age, treated for post ligation cardiac syndrome.. Adverse events experienced by neonates receiving milrinone. ;Timepoint(s) of evaluation of this end point: Pharmacokinetic parameters are evaluated during the 24 hour treatment period and 12 hours after the end of treatment with IMP. Adverse events are recorded until 7 days after the end of treatment with IMP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacodynamics of milrinone, including effects on blood pressure, heart rate and percutaneous oxygen saturation; central haemodynamics (LVO, RVO, ejection fraction, myocardial shortening fraction and tissue Doppler velocities) assessed by heart ultrasonography, regional cerebral perfusion (rScO2, cFTOE), assessed by NIRS and microcirculation, assessed by SDF imaging in neonates undergoing PDA ligation with and without milrinone treatment. Clinical and biochemical measures of systemic hypoperfusion, including blood gases, lactate; diuresis. Clinical outcome at FU visit – survival, duration of respiratory and vasoactive support. Neurological evaluation as assessed by cerebral ultrasound (and if persistently abnormal, by MRI or CT) at any time up until the FU visit; ;Timepoint(s) of evaluation of this end point: The pharmacodynamic effect of milrinone is evaluated during 24 hour treatment period, haemodynamic parameters are recorded continuously or 3 and 24 hours after the start of treatment (heart ultrasonography and videocapillaroscopy). Clinical and biochemical measures of hypoperfusion are taken every 6 hours during the treatment period. FU visit is 7 days after the end of treatment with IMP. | — |
Countries
Estonia
Contacts
Public ContactDepartment of Anaesthesiology
University of Tartu
Outcome results
None listed