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
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
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Epinephrine (DRUG)IV Low dose Boluses
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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
Study Design
Study type: | INTERVENTIONAL |
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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 |
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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.
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
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Patients suffering from acute hypo-tension will receive low dose IV epinephrine boluses ≤ 5 μg/kg/dose, 3 doses, within 3 hours
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Patients suffering from acute hypo-tension will be managed according to Traditional algorithm of Hypotension
Eligibility Criteria
Sex: | All |
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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
* 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
More Details
NCT Number: | NCT03671070 |
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Other IDs: | RLDEBAH |
Study URL: | https://clinicaltrials.gov/study/NCT03671070 |
Last updated: Sep 29, 2023