Role of Low Dose Epinephrine Boluses In Acute Hypotension

NCT03671070 | Unknown

• 1 other identifier: RLDEBAH
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypotension and Shock

Outcome Measures

Primary Outcomes (1)

• 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

  within 1 Hours after injection

Study Arms (2)

Low dose Epinephrine boluses

ACTIVE COMPARATOR

Patients suffering from acute hypo-tension will receive low dose IV epinephrine boluses ≤ 5 μg/kg/dose, 3 doses, within 3 hours

Drug: Epinephrine

Traditional management of shock

PLACEBO COMPARATOR

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

Drug: Traditional management of shock

Interventions

Epinephrine DRUG

IV Low dose Boluses

Also known as: Adrenaline

Low dose Epinephrine boluses

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.

Also known as: Traditional management of hypotension

Traditional management of shock

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients experiencing acute hypotensive episodes whether brief or during or after medical or surgical procedures

You may not qualify if:

• Patients experiencing acute hypotensive episodes in arrest or pre-arrest situations

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 29319635 RESULT

MeSH Terms

Conditions

Hypotension; Shock

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Maher M Ahmed, Professer

CONTACT

+201062052802; maher61ahmed@aun.edu.eg

Mostafa M Embaby, Lecturer

CONTACT

+201006244311; mustafa_embaby@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 14, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share