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Dobutamine Versus Milrinone in Management of Critically Ill Low Cardiac Output Pediatric Patients at Cairo University Children's Hospital

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05999487
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to detect wither dobutamine or milrinone have a privilege in the management of low cardiac output pediatric patients over the other.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Randomized controlled trials (RCTs) enrolling critically ill patients with low cardiac output syndrome (LCOS) admitted at pediatrics emergency and intensive care units ,Cairo University Children's Hospital, identified by treating medical team as requiring initiation of inotropic therapy based on healthcare team assessment of :

  • Capillary refill time > 3 sec

  • Hypotension (less than the 5th percentile or less than 90/50 mmHg for children 10 years or older (Kleinman et al.,2010) (Haque et al .,2007)

  • Oliguria (urine output that is less than 1 mL/kg/h in infants, less than 0.5 mL/kg/h in children ) (Nakano et al.,2022)

  • Metabolic acidosis with base excess > -2 (Nakano et al.,2020)

Patient randomization will be done by a computer based generation , serial enveloped numbers will be taken for the patients. Cardiac assessment will be done by a blinded pediatric cardiologist. If at any time the randomly assigned therapy considered to be failed or unsafe to continue, the treating physician will discontinue randomization and will continue with the appropriate medication according to the patients need.

Every patient will be evaluated after the first 24 hours of starting the inotropic therapy by :

  • pre and post inotropic therapy ICON measurements ( evaluating cardiac index and systemic vascular resistance pre and post inotropic support)

  • pre and post inotropic therapy echocardiography ( evaluating systolic and diastolic dysfunction by M-mode and two dimensional methods) through measuring LV EDD cm, LV ESD cm, LV EDV ml, LVESV ml, FS% , LV mass, EF% , MAPSE cm, TAPSE cm.

  • pre and post inotropic therapy clinical assessment of vital signs (heart rate , blood pressure, capillary refill time and urine output as mention before)

  • The need of titration up of inotropes :

Milrinone will start by 0.25 , 0.5 , 0.75 we can titrate up with time interval 3 hours after re-assessment.

Dobutamine will start by 5, 10 , 15, 20 we can titrate with time interval 15 mins after re-assesment.

-Time to achievement of therapeutic endpoints for hemodynamics

  • adequate blood pressure

  • clinically adequate cardiac output ( capillary refill time < 2sec , urine output that is more than 1 mL/kg/h in infants, more than 0.5 mL/kg/h in children, full conscious )

Data will be collected for each patient in form of [ Time Frame: Through first 24 hours up to first week since admission ] :

  1. Total time on inotropes (in hours)

  2. Non-invasive or invasive mechanical ventilation Total number of days requiring non-invasive or invasive mechanical ventilation

  3. Change in cardiac index ([CI] measured with ICON

  4. Change in systemic vascular resistance [SVR] measured with ICON

  5. Presence of acute kidney injury (defined as an increase in serum creatinine or a decrease in urine output or both over hours to days.) (Jacob J et al.,2020)

  6. Absence of metabolic acidosis (BE -2 to 2)

  7. Arrhythmia requiring medical team intervention, either through electrical or chemical cardioversion or any intravenous anti-arrhythmia medication administration

  8. Need for up-titration or addition of new vasopressor therapy

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Masking Description:
. Cardiac assessment will be done by a blinded pediatric cardiologist.
Primary Purpose:
Treatment
Official Title:
Dobutamine Versus Milrinone in Management of Critically Ill Low Cardiac Output Pediatric Patients at Cairo University Children's Hospital
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: patients who will recieve dobutrex

patient presenting with acute heart failure , who will recieve dobutrex as a result of their randomixation , startng dose will be 5 mic , assesing their need for tittration of dose , the need for addition of another inotrope , the prescence of any side effects and the duration of inotropic use for reaching hemodynamically stable state

Drug: Dobutamine
Patient randomization will be done by a computer based generation , serial enveloped numbers will be taken for the patients. Cardiac assessment will be done by a blinded pediatric cardiologist. If at any time the randomly assigned therapy considered to be failed or unsafe to continue, the treating physician will discontinue randomization and will continue with the appropriate medication according to the patients need. Milrinone will start by 0.25 , 0.5 , 0.75 we can titrate up with time interval 3 hours after re-assessment. Dobutamine will start by 5, 10 , 15, 20 we can titrate with time interval 15 mins after re-assesment.
Other Names:
  • milrinone

    		•
    Experimental: patients who will recieve milirinone

    patient presenting with acute heart failure , who will recieve milirinone as a result of their randomixation , startng dose will be 0.25 mic , assesing their need for tittration of dose , the need for addition of another inotrope , the prescence of any side effects and the duration of inotropic use for reaching hemodynamically stable state

    Drug: Dobutamine
    Patient randomization will be done by a computer based generation , serial enveloped numbers will be taken for the patients. Cardiac assessment will be done by a blinded pediatric cardiologist. If at any time the randomly assigned therapy considered to be failed or unsafe to continue, the treating physician will discontinue randomization and will continue with the appropriate medication according to the patients need. Milrinone will start by 0.25 , 0.5 , 0.75 we can titrate up with time interval 3 hours after re-assessment. Dobutamine will start by 5, 10 , 15, 20 we can titrate with time interval 15 mins after re-assesment.
    Other Names:
  • milrinone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. time to achievemnets of theraputeic endpoints of hemodynamics [first 24 hrs]

      ( normal blood pressure and clinically adequate cardiac output)

    Secondary Outcome Measures

    1. Correlation between the used inotropic support and the survival to discharge . [first week]

    2. Total time on inotropes and average length of stay at a pediatric intensive care unit. [first week]

    3. Need for up-titration or addition of other inotropic support. [first 24 hrs]

    4. Frequency of arrythmias and side effects encountered with the use of inotropic support in pediatrics population. [first 24 hrs]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 1-Patients from age of 1 month to 14 years old of both sexes.

    2-Patients presenting with fluid refractory shock with low cardiac output state, evidenced by sustained hypotension (systolic blood pressure below 5th percentile for age) and end organ dysfunction (altered level of consciousness, renal or hepatic dysfunction)

    3-Clinical evidence of systemic and/or pulmonary congestion despite use of vasodilators and/or diuretics

    4-Refractory heart failure requiring admission for inotropic support.

    Exclusion Criteria:

    1-All other causes of pediatric shock not in need for inotropic support (eg.isolated hypovolemic shock, anaphylaxis,….)

    2 - patients not fit for randomization needing specific line of management (eg. Sever hypotension patients with good filling pressure unfit for milrinone , patients previously known having sever pulmonary hypertension not fit for dobutamine ,…)

    3-post cardiac surgery patients with low cardiac output manifestation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Children'S Hospital Giza Egypt 11511

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Nada Gamal, pediatric resident, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05999487
    Other Study ID Numbers:
    • inotropes in pediatrics
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiac Output, Low
    Dobutamine
    Milrinone

    Study Results

    No Results Posted as of Aug 21, 2023