Role of Low Dose Epinephrine Boluses In Acute Hypotension

• ClinicalTrials.gov Identifier: NCT03671070
• Recruitment Status: Unknown
• First Posted: September 14, 2018
• Last Update Posted: September 14, 2018
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mohamed E Eldaly, Assiut University

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

Condition or disease	Intervention/treatment	Phase
Hypotension and Shock	Drug: Epinephrine; Drug: Traditional management of shock	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Role of Low Dose Epinephrine Boluses For Acute Hypotension in The Pediatrics ICU
• Estimated Study Start Date: January 1, 2019
• Estimated Primary Completion Date: January 1, 2021
• Estimated Study Completion Date: September 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Low dose Epinephrine boluses; Patients suffering from acute hypo-tension will receive low dose IV epinephrine boluses ≤ 5 μg/kg/dose, 3 doses, within 3 hours	Drug: Epinephrine; IV Low dose Boluses; Other Name: Adrenaline
Placebo Comparator: Traditional management of shock; Patients suffering from acute hypo-tension will be managed according to Traditional algorithm of Hypotension	Drug: Traditional management of shock; 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.; Other Name: Traditional management of hypotension

Outcome Measures

Primary Outcome Measures :

1. change of mean value of blood Pressure both systolic and diastolic according to age group [ Time Frame: within 1 Hours after injection ]
   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

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Maher M Ahmed, Professer; +201062052802; maher61ahmed@aun.edu.eg

Contact: Mostafa M Embaby, Lecturer; +201006244311; mustafa_embaby@aun.edu.eg

Sponsors and Collaborators

Assiut University

More Information

Publications of Results:

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.

• Responsible Party: Mohamed E Eldaly, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03671070
• Other Study ID Numbers: RLDEBAH
• First Posted: September 14, 2018
• Last Update Posted: September 14, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypotension; Vascular Diseases; Cardiovascular Diseases; Epinephrine; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Adrenergic beta-Agonists; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Sympathomimetics; Vasoconstrictor Agents