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Role of Low Dose Epinephrine Boluses In Acute Hypotension

Role of Low Dose Epinephrine Boluses For Acute Hypotension in The Pediatrics ICU

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03671070
Enrollment
50
Registered
2018-09-14
Start date
2019-01-01
Completion date
2021-09-01
Last updated
2018-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension and Shock

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.

Interventions

DRUGEpinephrine

IV Low dose Boluses

DRUGTraditional management of shock

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change of mean value of blood Pressure both systolic and diastolic according to age groupwithin 1 Hours after injectionAssessment 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

Contacts

Primary ContactMaher M Ahmed, Professer
maher61ahmed@aun.edu.eg+201062052802
Backup ContactMostafa M Embaby, Lecturer
mustafa_embaby@aun.edu.eg+201006244311

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026