Timely Administration of IV Magnesium Sulfate in Patients With a Moderate Asthma Exacerbation

NCT06137040 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 16339
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children; Asthma Attack

Keywords

asthma exacerbation; magnesium sulfate; asthma; asthma attack

Outcome Measures

Primary Outcomes (1)

• Change in Length of Stay in Patients who receive IV Magnesium within the first hour (experimental group) vs control group

  Evaluating whether timely administration of IV magnesium sulfate in moderate asthma exacerbations can reduce length of stay in the ED, general hospital bed or PICU. The data will also be analyzed to determine if more patients in the experimental group were able to be discharged from the emergency department compared to the control group.

  From initiation of therapy to discharge from the emergency department or admitting unit, up to 1 week

Secondary Outcomes (1)

• Evaluate the need for respiratory support in patients receiving magnesium sulfate within the first hour (experimental group) vs control group

  Time of initiation of therapy to discharge from the hospital, up to 2 weeks

Study Arms (2)

Magnesium Sulfate in the first hour

EXPERIMENTAL

These patients will receive 40-50 mg/kg IV magnesium sulfate within the first hour of treatment alongside all first line asthma exacerbation therapies (ie inhaled beta agonists, IV steroids).

Drug: Magnesium Sulfate within the first hour

No Magnesium Sulfate

PLACEBO COMPARATOR

These patients will not receive IV magnesium sulfate within the first hour of treatment but may receive it later if the provider feels it is clinically necessary.

Other: No Magnesium sulfate within the first hour

Interventions

Magnesium Sulfate within the first hour DRUG

The experimental group will receive 40-50 mg/kg of IV magnesium sulfate will be given to the experimental group alongside the first line asthma therapies (ie inhaled beta agonists, IV steroids). This will be given with a 20 mL/kg normal saline bolus (max 1000 mL) to avoid possible hypotension. 15-19 kg: 750 mg 20-29 kg: 1000 mg 30-39 kg: 1500 mg \>40 kg: 2000 mg

Also known as: Magnesium within the first hour

Magnesium Sulfate in the first hour

No Magnesium sulfate within the first hour OTHER

The control group will not receive IV magnesium sulfate within the first hour of treatment.

Also known as: No magnesium within the first hour

No Magnesium Sulfate

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Oklahoma Children's Hospital

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 15613519 BACKGROUND

• 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.

  PMID: 25024668 BACKGROUND

• 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.

  PMID: 27218606 BACKGROUND

• 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.

  PMID: 29305409 BACKGROUND

• 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.

  PMID: 22859321 BACKGROUND

• 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.

  PMID: 10796650 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ryan McKee, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan McKee, MD

CONTACT

4056308997; ryan-mckee@ouhsc.edu

Jaclyn Urquiola Sorzano, DO

CONTACT

7863906297; jaclyn-urquiola@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Since the study is randomized, the participant and the provider will not know which group the enrolled patient will be in until the patient is randomized to a group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: November 18, 2023
• Study Start: November 30, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)