Role of Low Dose Epinephrine Boluses In Acute Hypotension

NCT ID: NCT03671070

Last Updated: 2018-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-09-01

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.

Conditions

Hypotension and Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Epinephrine

Intervention Type: DRUG

IV Low dose Boluses

Traditional management of shock

Patients suffering from acute hypo-tension will be managed according to Traditional algorithm of Hypotension

Group Type: PLACEBO_COMPARATOR

Traditional management of shock

Intervention Type: 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.

Interventions

Epinephrine

IV Low dose Boluses

Intervention Type: DRUG

Traditional 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.

Intervention Type: DRUG

Other Intervention Names

Adrenaline; Traditional management of hypotension

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed E Eldaly

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Maher M Ahmed, Professer

Role: CONTACT

maher61ahmed@aun.edu.eg

+201062052802

Mostafa M Embaby, Lecturer

Role: CONTACT

mustafa_embaby@aun.edu.eg

+201006244311

References

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.

Reference Type: RESULT

PMID: 29319635 (View on PubMed)

Other Identifiers

RLDEBAH

Identifier Type: -

Identifier Source: org_study_id