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NCT Number: NCT06137040

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

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.

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Oklahoma Children's Hospital

Oklahoma City, Oklahoma, 73104, United States

Location status: Recruiting

Location contact

Ryan McKee, MD

CONTACT

[email protected]

405-271-2429

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Magnesium within 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.

Other names: No magnesium within the first hour

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jaclyn Urquiola Sorzano, DO

CONTACT

[email protected]

7863906297

Ryan McKee, MD

CONTACT

[email protected]

4056308997

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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