Role of Low Dose Epinephrine Boluses In Acute Hypotension

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

Intervention / Treatment

  • Epinephrine (DRUG)
    IV Low dose Boluses
  • Traditional management of shock (DRUG)
    1. 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 2. 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. 3. Catecholamine resistant shock: Begin hydrocortisone if at risk for absolute adrenal insufficiency.

Condition or Disease

  • Hypotension and Shock

Phase

  • Not Applicable
  • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 1 Month to 18 Years
    Enrollment: 50 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Jan 01, 2019 ESTIMATED
    Primary Completion: Jan 01, 2021 ESTIMATED
    Completion Date: Sep 01, 2021 ESTIMATED
    Study First Posted: Sep 14, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 13, 2018

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    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.

    Participant Groups

    • 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

    Eligibility Criteria

    Sex: All
    Maximum Age: 18
    Age Groups: Child / Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • 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

    More Details

    NCT Number: NCT03671070
    Other IDs: RLDEBAH
    Study URL: https://clinicaltrials.gov/study/NCT03671070
    Last updated: Sep 29, 2023