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

Primary Purpose

Dobutamine, Milrinone , Pediatrics , Low Cardiac Output

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dobutamine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dobutamine, Milrinone , Pediatrics , Low Cardiac Output

Eligibility Criteria

1 Month - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo University Children'S Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

patients who will recieve dobutrex

patients who will recieve milirinone

Arm Description

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

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

Outcomes

Primary Outcome Measures

time to achievemnets of theraputeic endpoints of hemodynamics
( normal blood pressure and clinically adequate cardiac output)

Secondary Outcome Measures

Correlation between the used inotropic support and the survival to discharge .
Total time on inotropes and average length of stay at a pediatric intensive care unit.
Need for up-titration or addition of other inotropic support.
Frequency of arrythmias and side effects encountered with the use of inotropic support in pediatrics population.

Full Information

First Posted
May 5, 2023
Last Updated
August 17, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05999487
Brief Title
Dobutamine Versus Milrinone in Management of Critically Ill Low Cardiac Output Pediatric Patients at Cairo University Children's Hospital
Official Title
Dobutamine Versus Milrinone in Management of Critically Ill Low Cardiac Output Pediatric Patients at Cairo University Children's Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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 ] : Total time on inotropes (in hours) Non-invasive or invasive mechanical ventilation Total number of days requiring non-invasive or invasive mechanical ventilation Change in cardiac index ([CI] measured with ICON Change in systemic vascular resistance [SVR] measured with ICON 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) Absence of metabolic acidosis (BE -2 to 2) Arrhythmia requiring medical team intervention, either through electrical or chemical cardioversion or any intravenous anti-arrhythmia medication administration Need for up-titration or addition of new vasopressor therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dobutamine, Milrinone , Pediatrics , Low Cardiac Output

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Masking Description
. Cardiac assessment will be done by a blinded pediatric cardiologist.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients who will recieve dobutrex
Arm Type
Active Comparator
Arm Description
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
Arm Title
patients who will recieve milirinone
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Other Intervention Name(s)
milrinone
Intervention Description
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.
Primary Outcome Measure Information:
Title
time to achievemnets of theraputeic endpoints of hemodynamics
Description
( normal blood pressure and clinically adequate cardiac output)
Time Frame
first 24 hrs
Secondary Outcome Measure Information:
Title
Correlation between the used inotropic support and the survival to discharge .
Time Frame
first week
Title
Total time on inotropes and average length of stay at a pediatric intensive care unit.
Time Frame
first week
Title
Need for up-titration or addition of other inotropic support.
Time Frame
first 24 hrs
Title
Frequency of arrythmias and side effects encountered with the use of inotropic support in pediatrics population.
Time Frame
first 24 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nada gamal
Phone
01062094645
Email
nada.g276@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hafez Bazraa, professor
Phone
01222235316
Email
hmbazaraa@kasralainy.edu.eg
Facility Information:
Facility Name
Cairo University Children'S Hospital
City
Giza
ZIP/Postal Code
11511
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
17273118
Citation
Haque IU, Zaritsky AL. Analysis of the evidence for the lower limit of systolic and mean arterial pressure in children. Pediatr Crit Care Med. 2007 Mar;8(2):138-44. doi: 10.1097/01.PCC.0000257039.32593.DC.
Results Reference
background
PubMed Identifier
33121629
Citation
Jacob J, Dannenhoffer J, Rutter A. Acute Kidney Injury. Prim Care. 2020 Dec;47(4):571-584. doi: 10.1016/j.pop.2020.08.008. Epub 2020 Oct 1.
Results Reference
background
PubMed Identifier
25432872
Citation
Jentzer JC, Coons JC, Link CB, Schmidhofer M. Pharmacotherapy update on the use of vasopressors and inotropes in the intensive care unit. J Cardiovasc Pharmacol Ther. 2015 May;20(3):249-60. doi: 10.1177/1074248414559838. Epub 2014 Nov 28.
Results Reference
background
PubMed Identifier
20956434
Citation
Kleinman ME, Chameides L, Schexnayder SM, Samson RA, Hazinski MF, Atkins DL, Berg MD, de Caen AR, Fink EL, Freid EB, Hickey RW, Marino BS, Nadkarni VM, Proctor LT, Qureshi FA, Sartorelli K, Topjian A, van der Jagt EW, Zaritsky AL; American Heart Association. Pediatric advanced life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Pediatrics. 2010 Nov;126(5):e1361-99. doi: 10.1542/peds.2010-2972D. Epub 2010 Oct 18. No abstract available.
Results Reference
background
PubMed Identifier
30175599
Citation
Lewis TC, Aberle C, Altshuler D, Piper GL, Papadopoulos J. Comparative Effectiveness and Safety Between Milrinone or Dobutamine as Initial Inotrope Therapy in Cardiogenic Shock. J Cardiovasc Pharmacol Ther. 2019 Mar;24(2):130-138. doi: 10.1177/1074248418797357. Epub 2018 Sep 2.
Results Reference
background
PubMed Identifier
34347952
Citation
Mathew R, Di Santo P, Jung RG, Marbach JA, Hutson J, Simard T, Ramirez FD, Harnett DT, Merdad A, Almufleh A, Weng W, Abdel-Razek O, Fernando SM, Kyeremanteng K, Bernick J, Wells GA, Chan V, Froeschl M, Labinaz M, Le May MR, Russo JJ, Hibbert B. Milrinone as Compared with Dobutamine in the Treatment of Cardiogenic Shock. N Engl J Med. 2021 Aug 5;385(6):516-525. doi: 10.1056/NEJMoa2026845.
Results Reference
background
PubMed Identifier
16344207
Citation
Masse L, Antonacci M. Low cardiac output syndrome: identification and management. Crit Care Nurs Clin North Am. 2005 Dec;17(4):375-83, x. doi: 10.1016/j.ccell.2005.07.005.
Results Reference
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PubMed Identifier
31970993
Citation
Nakano H, Nagai T, Honda Y, Honda S, Iwakami N, Matsumoto C, Asaumi Y, Aiba T, Noguchi T, Kusano K, Yokoyama H, Ogawa H, Yasuda S, Chikamori T, Anzai T. Prognostic value of base excess as indicator of acid-base balance in acute heart failure. Eur Heart J Acute Cardiovasc Care. 2020 Aug;9(5):399-405. doi: 10.1177/2048872619898781. Epub 2020 Jan 23.
Results Reference
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Citation
Nakano H. Oliguria. https://emedicine.medscape.com/article/983156-overview. Updated: Feb 28, 2022. Accessed at 15-12-2022.
Results Reference
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PubMed Identifier
33152122
Citation
Uhlig K, Efremov L, Tongers J, Frantz S, Mikolajczyk R, Sedding D, Schumann J. Inotropic agents and vasodilator strategies for the treatment of cardiogenic shock or low cardiac output syndrome. Cochrane Database Syst Rev. 2020 Nov 5;11(11):CD009669. doi: 10.1002/14651858.CD009669.pub4.
Results Reference
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Dobutamine Versus Milrinone in Management of Critically Ill Low Cardiac Output Pediatric Patients at Cairo University Children's Hospital

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