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Role of Low Dose Epinephrine Boluses In Acute Hypotension

Primary Purpose

Hypotension and Shock

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Epinephrine
Traditional management of shock
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension and Shock

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients experiencing acute hypotensive episodes whether brief or during or after medical or surgical procedures

Exclusion Criteria:

  • Patients experiencing acute hypotensive episodes in arrest or pre-arrest situations

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Low dose Epinephrine boluses

    Traditional management of shock

    Arm Description

    Patients suffering from acute hypo-tension will receive low dose IV epinephrine boluses ≤ 5 μg/kg/dose, 3 doses, within 3 hours

    Patients suffering from acute hypo-tension will be managed according to Traditional algorithm of Hypotension

    Outcomes

    Primary Outcome Measures

    change of mean value of blood Pressure both systolic and diastolic according to age group
    Assessment of patients' blood Pressure (both systolic and diastolic) will be at at the onset of acute hypo-tension and after every bolus of low dose epinephrine and pressure will be reassessed after 20 minutes from each bolus

    Secondary Outcome Measures

    Full Information

    First Posted
    September 7, 2018
    Last Updated
    September 13, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03671070
    Brief Title
    Role of Low Dose Epinephrine Boluses In Acute Hypotension
    Official Title
    Role of Low Dose Epinephrine Boluses For Acute Hypotension in The Pediatrics ICU
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    January 1, 2021 (Anticipated)
    Study Completion Date
    September 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    The Study evaluates the role of low dose epinephrine boluses in management of acute hypo-tension VS The Traditional management of acute hypo-tension. Half of the participants suffering from acute hypo-tension will receive low dose epinephrine boluses (≤ 5 µg/kg/dose) and the other half will receive traditional management of shock
    Detailed Description
    Epinephrine, due to its alpha-1 and beta-adrenergic effects, is considered an important part of the management of children with hypo-tension. Epinephrine is typically used as a continuous infusion (0.02-0.5 μg/kg/min) for severe sustained hypo-tension and as a bolus (0.01 mg/kg, maximum dose = 1 mg) for bradycardia, asystole, or pulse-less arrest. There are, however, clinical conditions that may benefit from smaller doses of bolus epinephrine. For example, brief periods of hypo-tension during medical procedures, intermittent hemodynamic instability, and augmentation of low blood pressure in a pre-arrest condition. While a resuscitation (or code) dose of epinephrine would be inappropriate (as it would cause an unacceptable large increase in blood pressure and heart rate [HR]), a smaller dose may be particularly useful. Low-dose bolus vasopressors have been used for decades by anaesthesiologists to prevent post-re-perfusion injury after solid organ transplant, control cerebral oxygenation during anaesthesia and manage acute hypo-tension during spinal surgery. Recently, use of bolus dose phenyl-ephrine has been described in the emergency department setting to augment blood pressure during periods of hypo-tension surrounding intubation. Finally, free open access medical publications have provided some insight into using bolus dose pressors for acute hypotensive episodes in adults. However, there is few published data describing the use of low-dose vasopressor boluses in children.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension and Shock

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low dose Epinephrine boluses
    Arm Type
    Active Comparator
    Arm Description
    Patients suffering from acute hypo-tension will receive low dose IV epinephrine boluses ≤ 5 μg/kg/dose, 3 doses, within 3 hours
    Arm Title
    Traditional management of shock
    Arm Type
    Placebo Comparator
    Arm Description
    Patients suffering from acute hypo-tension will be managed according to Traditional algorithm of Hypotension
    Intervention Type
    Drug
    Intervention Name(s)
    Epinephrine
    Other Intervention Name(s)
    Adrenaline
    Intervention Description
    IV Low dose Boluses
    Intervention Type
    Drug
    Intervention Name(s)
    Traditional management of shock
    Other Intervention Name(s)
    Traditional management of hypotension
    Intervention Description
    Initial resuscitation: Push boluses of 20 cc/kg isotonic saline or colloid up to and over 60 cc/kg until perfusion improves or unless rales or hepatomegaly develop Fluid refractory shock: Begin inotrope IV/IO. Use atropine/ketamine IV/IO/IM to obtain central access and airway if needed. Reverse cold shock by titrating central dopamine or, if resistant, titrate central epinephrine. Reverse warm shock by titrating central norepinephrine. Catecholamine resistant shock: Begin hydrocortisone if at risk for absolute adrenal insufficiency.
    Primary Outcome Measure Information:
    Title
    change of mean value of blood Pressure both systolic and diastolic according to age group
    Description
    Assessment of patients' blood Pressure (both systolic and diastolic) will be at at the onset of acute hypo-tension and after every bolus of low dose epinephrine and pressure will be reassessed after 20 minutes from each bolus
    Time Frame
    within 1 Hours after injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients experiencing acute hypotensive episodes whether brief or during or after medical or surgical procedures Exclusion Criteria: Patients experiencing acute hypotensive episodes in arrest or pre-arrest situations
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maher M Ahmed, Professer
    Phone
    +201062052802
    Email
    maher61ahmed@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mostafa M Embaby, Lecturer
    Phone
    +201006244311
    Email
    mustafa_embaby@aun.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29319635
    Citation
    Reiter PD, Roth J, Wathen B, LaVelle J, Ridall LA. Low-Dose Epinephrine Boluses for Acute Hypotension in the PICU. Pediatr Crit Care Med. 2018 Apr;19(4):281-286. doi: 10.1097/PCC.0000000000001448.
    Results Reference
    result

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    Role of Low Dose Epinephrine Boluses In Acute Hypotension

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