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

NCT05999487 | Unknown

• 1 other identifier: inotropes in pediatrics
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dobutamine, Milrinone , Pediatrics , Low Cardiac Output

Outcome Measures

Primary Outcomes (1)

• time to achievemnets of theraputeic endpoints of hemodynamics

  ( normal blood pressure and clinically adequate cardiac output)

  first 24 hrs

Secondary Outcomes (4)

• Correlation between the used inotropic support and the survival to discharge .

  first week

• Total time on inotropes and average length of stay at a pediatric intensive care unit.

  first week

• Need for up-titration or addition of other inotropic support.

  first 24 hrs

• Frequency of arrythmias and side effects encountered with the use of inotropic support in pediatrics population.

  first 24 hrs

Study Arms (2)

patients who will recieve dobutrex

ACTIVE COMPARATOR

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

patients who will recieve milirinone

EXPERIMENTAL

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

Interventions

Dobutamine DRUG

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.

Also known as: milrinone

patients who will recieve dobutrex; patients who will recieve milirinone

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients from age of 1 month to 14 years old of both sexes.
• 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)
• Clinical evidence of systemic and/or pulmonary congestion despite use of vasodilators and/or diuretics
• Refractory heart failure requiring admission for inotropic support.

You may not qualify if:

• All other causes of pediatric shock not in need for inotropic support (eg.isolated hypovolemic shock, anaphylaxis,….)
• 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 ,…)
• post cardiac surgery patients with low cardiac output manifestation.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Children'S Hospital

Giza, 11511, Egypt

Location

Related Publications (10)

• 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.

  PMID: 17273118 BACKGROUND

• 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.

  PMID: 33121629 BACKGROUND

• 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.

  PMID: 25432872 BACKGROUND

• 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.

  PMID: 20956434 BACKGROUND

• 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.

  PMID: 30175599 BACKGROUND

• 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.

  PMID: 34347952 BACKGROUND

• 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.

  PMID: 16344207 BACKGROUND

• 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.

  PMID: 31970993 BACKGROUND

• Nakano H. Oliguria. https://emedicine.medscape.com/article/983156-overview. Updated: Feb 28, 2022. Accessed at 15-12-2022.

  BACKGROUND

• 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.

  PMID: 33152122 BACKGROUND

MeSH Terms

Conditions

Cardiac Output, Low

Interventions

Dobutamine; Milrinone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Amrinone; Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

nada gamal

CONTACT

01062094645; nada.g276@gmail.com

Hafez Bazraa, professor

CONTACT

01222235316; hmbazaraa@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: . Cardiac assessment will be done by a blinded pediatric cardiologist.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatric resident

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: August 21, 2023
• Study Start: October 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

EG (1)