Neonates and Preterm Infants
Conditions
Brief summary
The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of dopamine which is used as treatment of hypotension in neonate and preterm infant.
Interventions
DRUGDopamine
Dopamine treatment
Sponsors
Asan Medical Center
Severance Hospital
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
No
Inclusion criteria
* Admitted at NICU in Seoul National University Hospital, Seoul Asan Hospital or Severance Hospital * Infants who were diagnosed with hypotension
Exclusion criteria
* Congenital heart disease * Chromosomal anomaly * Treated with ECMO or CRRT * Arrhythmia * Hypovolemic state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steady state concentration of dopamine (Css) at 2mcg/kg/min | After continuous infusion for more than 30 minutes at 2mcg/kg/min | dopamine drug level in blood |
| Steady state concentration of dopamine (Css) at 5mcg/kg/min | After continuous infusion for more than 30 minutes at 5mcg/kg/min | dopamine drug level in blood |
| Steady state concentration of dopamine (Css) at 10mcg/kg/min | After continuous infusion for more than 30 minutes at 10mcg/kg/min | dopamine drug level in blood |
| Steady state concentration of dopamine (Css) at 15mcg/kg/min | After continuous infusion for more than 30 minutes at 15mcg/kg/min | dopamine drug level in blood |
| Steady state concentration of dopamine (Css) at 20mcg/kg/min | After continuous infusion for more than 30 minutes at 20mcg/kg/min | dopamine drug level in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fractional shortening from Echocardiography | After continuous infusion for more than 30 minutes at 2mcg/kg/min | — |
| Blood pressure in mmHg at 2mcg/kg/min | After continuous infusion for more than 30 minutes at 2mcg/kg/min | Systolic, diastolic and mean blood pressure in mmHg |
| VTI (velocity time integral) from Echocardiography | After continuous infusion for more than 30 minutes at 2mcg/kg/min | the area within the spectral curve and indicates how far blood travels during the flow period |
| Tei index from Echocardiography | After continuous infusion for more than 30 minutes at 2mcg/kg/min | (Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms) |
| Blood pressure in mmHg at 5mcg/kg/min | After continuous infusion for more than 30 minutes at 5mcg/kg/min | Systolic, diastolic and mean blood pressure in mmHg |
| Blood pressure in mmHg at 10mcg/kg/min | After continuous infusion for more than 30 minutes at 10mcg/kg/min | Systolic, diastolic and mean blood pressure in mmHg |
| Heart rate | After continuous infusion for more than 30 minutes at 2mcg/kg/min | — |
| Ejection fraction from Echocardiography | After continuous infusion for more than 30 minutes at 2mcg/kg/min | — |
Countries
South Korea
Outcome results
None listed