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
About this trial
This is an interventional treatment trial for Hypotension and Shock
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
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
NCT ID
NCT03671070
First Posted
September 7, 2018
Last Updated
September 13, 2018
Sponsor
Assiut University
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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