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Electrolyte Supplement

50 mg/kg for Asthma (IMPACT-ED Trial)

Phase 2
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months of enrollment.
Awards & highlights

IMPACT-ED Trial Summary

This trial will test whether magnesium sulfate can be used in the emergency department to prevent hospitalization for children with severe asthma.

IMPACT-ED Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months of enrollment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months of enrollment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enrollment
Secondary outcome measures
Adverse events and safety profiles
Hospital course
Hospitalization
+2 more

IMPACT-ED Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: 50 mg/kgActive Control1 Intervention
Doses for each IVMg arm will be prepared in identical manner, by drawing a specified volume of IVMg from the commercial container using sterile technique and mixing in a polyvinylchloride container with a specified volume of sterile water. For the 50 mg/kg arm, this will be accomplished by mixing 25 mL of IVMg (80 mg/mL) with 15 mL of sterile water for a final concentration of 50 mg/mL and volume of 40 mL. After randomization the institutional pharmacist will draw equivolumetric dosages (1 mL/kg, with max of 40 mL) from previously prepared vials. The dose will be delivered by the clinical nurse over 20 minutes through a peripheral IV.
Group II: 75 mg/kgActive Control1 Intervention
Doses for each IVMg arm will be prepared in identical manner, by drawing a specified volume of IVMg from the commercial container using sterile technique and mixing in a polyvinylchloride container with a specified volume of sterile water. For the 75 mg/kg arm, this will be accomplished by mixing 37.5 mL of IVMg (80 mg/mL) with 2.5 mL of sterile water for a final concentration of 75 mg/mL and volume of 40 mL. After randomization the institutional pharmacist will draw equivolumetric dosages (1 mL/kg, with max of 40 mL) from previously prepared vials. The dose will be delivered by the clinical nurse over 20 minutes through a peripheral IV.
Group III: PlaceboPlacebo Group1 Intervention
For the placebo arm, 40 mL of 0.9% sodium chloride solution will be drawn into a polyvinylchloride container identical in appearance to the containers used for the IVMg arms. After randomization the institutional pharmacist will draw equivolumetric dosages (1 mL/kg, with max of 40 mL) from previously prepared vials. The dose will be delivered by the clinical nurse over 20 minutes through a peripheral IV.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,098 Previous Clinical Trials
1,778,578 Total Patients Enrolled
5 Trials studying Asthma
176,455 Patients Enrolled for Asthma
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,581,251 Total Patients Enrolled
13 Trials studying Asthma
4,689 Patients Enrolled for Asthma
Nationwide Children's HospitalOTHER
341 Previous Clinical Trials
5,220,451 Total Patients Enrolled
3 Trials studying Asthma
76 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study include middle-aged or older volunteers?

"According to the extremely specific age requirements set out in the eligibility criteria, patients must be aged between 2 and 17 in order to participate."

Answered by AI

What is the standard dosage of 75 mg/kg?

"Effective dosage for treating diarrhea, general surgery, and urine alkalinization therapy is 75 mg/kg."

Answered by AI

Is there still room for more people in this experiment?

"This study, which was first posted on September 12th 2022 according to clinicaltrials.gov, is still recruiting patients."

Answered by AI

How many test subjects are being monitored in this experiment?

"Yes, this is an ongoing clinical trial that was originally posted on September 12th, 2022 and last updated on October 3rd, 2022. They are looking for 90 individuals to participate at three different sites."

Answered by AI

Are there other similar tests that have been done with 75 mg/kg?

"In 2012, the efficacy of a 75 mg/kg dosage was first explored at Sieff Medical Center. As of now, 639 similar studies have been completed while 136 are still ongoing. A large portion of these active trials are being conducted in Philadelphia, Pennsylvania."

Answered by AI

To whom is this research project open?

"Children aged 2-17 who have a diagnosis of asthma can participate in this upcoming clinical trial. 90 patients are needed for the study."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
Children's Hospital of Philadelphia
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm interested in the asthma study because I'm looking for a cure.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Timely Intravenous Magnesium for Asthma in Children
Mike Johnson 2022. "Timely Intravenous Magnesium for Asthma in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05166811.
~20 spots leftby Apr 2025
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