Clinical trial NCT06137040: Timely Administration of IV Magnesium Sulfate in Patients With a Moderate Asthma Exacerbation
Official title: Timely Administration of IV Magnesium Sulfate in Patients With a Moderate Asthma Exacerbation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Asthma in Children
Asthma Attack
Keywords: asthma exacerbation
magnesium sulfate
asthma
asthma attack
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experiment group will receive magnesium sulfate within the first hour with all of the other first line treatments vs. control group will not receive magnesium sulfate within the first hour of treatment.
Primary purpose: TREATMENT

Brief summary: This study aims to identify whether early administration of magnesium sulfate in moderate asthma exacerbations can potentially avoid admission, decrease length of stay in the emergency department (ED), decrease length of stay (LOS) in the general hospital floor vs pediatric intensive care unit (PICU), and decrease the need for respiratory support.

Detailed description: Patients ages 5-17 presenting to the OU Children's Hospital Emergency Department from October 2023 to July 2024 will be assigned a respiratory score (RS) upon presentation. Those with a RS between 6-9 (moderate exacerbation) will be screened for inclusion. Eligible patient will then be approached for consent. First line asthma therapies including bronchodilators and steroids will not be delayed for the consent process. Patients who consent will be randomized to the control vs. experimental group once consent is obtained.

The study will not be blinded once a patient is randomized to a group, the provider will know whether the patient will receive weight-based IV magnesium within the first hour (experimental group) or receive standard weight-based IV magnesium sulfate per the provider's clinical judgement (placebo group). Magnesium sulfate dosing for the experimental group will be as follows:

15-19 kg: 750 mg

20-29 kg: 1000 mg

30-39 kg: 1500 mg

\>40 kg: 2000 mg

Enrolled patients will have their clinical course reviewed and data obtained regarding LOS in ED and hospital stay, need for respiratory support, and or PICU LOS if applicable.

Eligibility criteria: Inclusion Criteria:

* Ages 5-17 years old
* Presents to the ED with a respiratory score in the "Moderate" range (6
* Parent(s)/Caregiver(s) speak English

Exclusion Criteria:

* Patients with chronic medical conditions including chronic pulmonary disease (other than asthma), cerebral palsy, congenital heart disease, tracheostomy dependent, myasthenia gravis patients
* Patients who are pregnant
* Parent(s)/Caregiver(s) do not speak English

Primary outcomes:
measure: Change in Length of Stay in Patients who receive IV Magnesium within the first hour (experimental group) vs control group
timeFrame: From initiation of therapy to discharge from the emergency department or admitting unit, up to 1 week
Secondary outcomes:
measure: Evaluate the need for respiratory support in patients receiving magnesium sulfate within the first hour (experimental group) vs control group
timeFrame: Time of initiation of therapy to discharge from the hospital, up to 2 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Children's Hospital
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Ryan McKee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheuk DK, Chau TC, Lee SL. A meta-analysis on intravenous magnesium sulphate for treating acute asthma. Arch Dis Child. 2005 Jan;90(1):74-7. doi: 10.1136/adc.2004.050005.
citation: Kokotajlo S, Degnan L, Meyers R, Siu A, Robinson C. Use of intravenous magnesium sulfate for the treatment of an acute asthma exacerbation in pediatric patients. J Pediatr Pharmacol Ther. 2014 Apr;19(2):91-7. doi: 10.5863/1551-6776-19.2.91.
citation: Liu X, Yu T, Rower JE, Campbell SC, Sherwin CM, Johnson MD. Optimizing the use of intravenous magnesium sulfate for acute asthma treatment in children. Pediatr Pulmonol. 2016 Dec;51(12):1414-1421. doi: 10.1002/ppul.23482. Epub 2016 May 24.
citation: Shein SL, Farhan O, Morris N, Mahmood N, Alter SJ, Biagini Myers JM, Gunkelman SM, Kercsmar CM, Khurana Hershey GK, Martin LJ, McCoy KS, Ruddy JR, Ross KR. Adjunctive Pharmacotherapies in Children With Asthma Exacerbations Requiring Continuous Albuterol Therapy: Findings From The Ohio Pediatric Asthma Repository. Hosp Pediatr. 2018 Jan 5;8(2):89-95. doi: 10.1542/hpeds.2017-0088. Online ahead of print.
citation: Torres S, Sticco N, Bosch JJ, Iolster T, Siaba A, Rocca Rivarola M, Schnitzler E. Effectiveness of magnesium sulfate as initial treatment of acute severe asthma in children, conducted in a tertiary-level university hospital: a randomized, controlled trial. Arch Argent Pediatr. 2012 Aug;110(4):291-6. doi: 10.5546/aap.2012.eng.291. English, Spanish.
citation: Rowe BH, Bretzlaff JA, Bourdon C, Bota GW, Camargo CA Jr. Magnesium sulfate for treating exacerbations of acute asthma in the emergency department. Cochrane Database Syst Rev. 2000;2000(2):CD001490. doi: 10.1002/14651858.CD001490.