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Dopamine in Neonate

Sponsor
Seoul National University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04525495
Collaborator
Asan Medical Center (Other), Severance Hospital (Other)
30
Enrollment
1
Location
1
Arm
33
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Neonates and Preterm Infants
Actual Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dopamine treatment

Drug: Dopamine
Dopamine treatment

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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 Outcome Measures

  1. 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

  2. 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

  3. 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

  4. Blood pressure in mmHg at 10mcg/kg/min [After continuous infusion for more than 30 minutes at 20mcg/kg/min]

    Systolic, diastolic and mean blood pressure in mmHg

  5. Heart rate [After continuous infusion for more than 30 minutes at 2mcg/kg/min]

  6. Heart rate [After continuous infusion for more than 30 minutes at 5mcg/kg/min]

  7. Heart rate [After continuous infusion for more than 30 minutes at 10mcg/kg/min]

  8. Heart rate [After continuous infusion for more than 30 minutes at 15mcg/kg/min]

  9. Heart rate [After continuous infusion for more than 30 minutes at 20mcg/kg/min]

  10. Ejection fraction from Echocardiography [After continuous infusion for more than 30 minutes at 2mcg/kg/min]

  11. Ejection fraction from Echocardiography [After continuous infusion for more than 30 minutes at 5mcg/kg/min]

  12. Ejection fraction from Echocardiography [After continuous infusion for more than 30 minutes at 10mcg/kg/min]

  13. Ejection fraction from Echocardiography [After continuous infusion for more than 30 minutes at 15mcg/kg/min]

  14. Ejection fraction from Echocardiography [After continuous infusion for more than 30 minutes at 20mcg/kg/min]

  15. Fractional shortening from Echocardiography [After continuous infusion for more than 30 minutes at 2mcg/kg/min]

  16. Fractional shortening from Echocardiography [After continuous infusion for more than 30 minutes at 5mcg/kg/min]

  17. Fractional shortening from Echocardiography [After continuous infusion for more than 30 minutes at 10mcg/kg/min]

  18. Fractional shortening from Echocardiography [After continuous infusion for more than 30 minutes at 15mcg/kg/min]

  19. Fractional shortening from Echocardiography [After continuous infusion for more than 30 minutes at 20mcg/kg/min]

  20. 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)

  21. Tei index from Echocardiography [After continuous infusion for more than 30 minutes at 5mcg/kg/min]

    (Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)

  22. Tei index from Echocardiography [After continuous infusion for more than 30 minutes at 10mcg/kg/min]

    (Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)

  23. Tei index from Echocardiography [After continuous infusion for more than 30 minutes at 15mcg/kg/min]

    (Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)

  24. Tei index from Echocardiography [After continuous infusion for more than 30 minutes at 20mcg/kg/min]

    (Mitral valve closure to opening time(ms)-LV ejection time(ms))/LV ejection time(ms)

  25. 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

  26. VTI (velocity time integral) from Echocardiography [After continuous infusion for more than 30 minutes at 5mcg/kg/min]

    the area within the spectral curve and indicates how far blood travels during the flow period

  27. VTI (velocity time integral) from Echocardiography [After continuous infusion for more than 30 minutes at 10mcg/kg/min]

    the area within the spectral curve and indicates how far blood travels during the flow period

  28. VTI (velocity time integral) from Echocardiography [After continuous infusion for more than 30 minutes at 15mcg/kg/min]

    the area within the spectral curve and indicates how far blood travels during the flow period

  29. VTI (velocity time integral) from Echocardiography [After continuous infusion for more than 30 minutes at 20mcg/kg/min]

    the area within the spectral curve and indicates how far blood travels during the flow period

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 1 Month
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Children's Hospital Seoul Korea, Republic of 110-744

Sponsors and Collaborators

  • Seoul National University Hospital
  • Asan Medical Center
  • Severance Hospital

Investigators

  • Principal Investigator: Han-Suk Kim, MD, PhD, Seoul National University Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04525495
Other Study ID Numbers:
  • DPMSNUH
First Posted:
Aug 25, 2020
Last Update Posted:
Aug 25, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Premature Birth
Dopamine

Study Results

No Results Posted as of Aug 25, 2020