Hypoperfusion status of preterm and term newborns during the first days of life.
Conditions
Interventions
Trade Name: Dobutamine Claris
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOBUTAMINE HYDROCHLORIDE
CAS Number: 52663-81-7
Concentration unit: mg/ml milligram(s)/mil
Sponsors
Department of Anaesthesiology and Intensive Care, University of Tartu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Postnatal age below 72 hours 2) Need for inotropic therapy (based on clinical and biochemical data) 3) Informed consent given by the parents or guardians 4) Arterial catheter and/or central venous catheter in place on clinical indication Are the trial subjects under 18? yes Number of subjects for this age range: 40 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) Congenital defect that impacts haemodynamics /response to inotropic therapy (congenital heart disease) 2) Congenital hydrops 3) Other unresolved cause of low blood flow (air leak) 4) Known metabolic disease 5) Informed consent from parents or guardians not obtained 6) Situation where the treating physician considers a different vasoactive treatment necessary/dobutamine contraindicated 7) Hypersensitivity to dobutamine or any other component of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the pharmacokinetics and pharmacodynamics of dobutamine in preterm and term neonates during the first days of life.;Secondary Objective: To find out the optimum dose of dobutamine in relation to organ perfusion in neonates and to assess the safety profile of dobutamine in preterm and term neonates during the first days of life. ;Primary end point(s): The pharmacokinetics of dobutamine in preterm and term neonates. Adverse events experienced by neonates receiving dobutamine. ;Timepoint(s) of evaluation of this end point: Pharmacokinetic parameters are evaluated during the treatment period and 15 min after the end of treatment with dobutamine. Adverse events are recorded until 24 hours after the end of treatment with dobutamine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The pharmacodynamic effect of dobutamine is evaluated during the treatment/intervention period (starts from the beginning of treatment with IMP and ends 30 min after the dobutamine dose escalation to the highest level of 15 or 20 µg/kg/min) , haemodynamic parameters are recorded continuously or 20-30 min after each dose escalation (heart ultrasonography and videocapillaroscopy). Clinical and biochemical measures of hypoperfusion are taken at the end of treatment/intervention period. FU visit is 24 hours after the end of treatment with dobutamine.;Secondary end point(s): Pharmacodynamics of dobutamine, including effects on blood pressure, heart rate and percutaneous oxygen saturation, central haemodynamics assessed by heart ultrasonography, regional cerebral perfusion assessed by NIRS and microcirculation, assessed by SDF imaging in neonates during first days of life. 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 at any time up until the FU visit. | — |
Countries
Estonia
Contacts
Public ContactDepartment of Anaesthesiology
University of Tartu
Outcome results
None listed