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

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137040
• Other study ID #: 16339
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 30, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: University of Oklahoma
• Contact: Ryan McKee, MD
• Phone: 4056308997
• Email: ryan-mckee[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma Attack
• Asthma in Children

Intervention

Drug:
• Magnesium Sulfate within the first hour
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

Other:
• No Magnesium sulfate within the first hour
The control group will not receive IV magnesium sulfate within the first hour of treatment.

Locations

Country	Name	City	State
United States	Oklahoma Children's Hospital	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the need for respiratory support in patients receiving magnesium sulfate within the first hour (experimental group) vs control group	Evaluating whether timely administration of IV magnesium sulfate in moderate asthma exacerbations can decrease the need for respiratory support including invasive and non-invasive respiratory support devices.	Time of initiation of therapy to discharge from the hospital, up to 2 weeks