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

NCT ID: NCT06137040

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Asthma in Children Asthma Attack

Keywords

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asthma exacerbation magnesium sulfate asthma asthma attack

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

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Magnesium Sulfate in the first hour

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).

Group Type EXPERIMENTAL

Magnesium Sulfate within the first hour

Intervention Type 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

No Magnesium Sulfate

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.

Group Type PLACEBO_COMPARATOR

No Magnesium sulfate within the first hour

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

No Magnesium sulfate within the first hour

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

Intervention Type OTHER

Other Intervention Names

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Magnesium within the first hour No magnesium within the first hour

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan McKee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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Oklahoma Children's Hospital

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ryan McKee, MD

Role: CONTACT

Phone: 4056308997

Email: [email protected]

Jaclyn Urquiola Sorzano, DO

Role: CONTACT

Phone: 7863906297

Email: [email protected]

Facility Contacts

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Ryan McKee, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 15613519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25024668 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27218606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29305409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22859321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10796650 (View on PubMed)

Other Identifiers

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16339

Identifier Type: -

Identifier Source: org_study_id