AsthmaPhase 2IMPACT-EDNCT05166811
Timely Intravenous Magnesium for Asthma in Children
A Phase 2 study testing Magnesium Sulfate, Heptahydrate and 0.9% saline in people with Asthma, run by University of Utah at 3 sites in United States.
Trial summary
Many children currently being hospitalized with severe asthma could potentially avoid hospitalization and be sent home if their treatment in the emergency department was more effective. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Magnesium Sulfate, Heptahydrate and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Sep 2022to 31 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A prior physician diagnosis of asthma confirmed by a treating physician in the ED who has spoken with the patient and family and reviewed the medical record (ED attending or fellow physician)
- Severe acute asthma, defined as a Pediatric Respiratory Assessment Measure (PRAM) score of 7 or greater as assessed by a treating physician at the time of screening using the study scoring instrument, which takes 60 seconds to complete
- Children 2-17 years of age
Who cannot join
- Known pregnancy (by patient or parent report) or positive pregnancy test on females 12 years of age and older
- Age-adjusted hypotension at presentation using age-based Pediatric Advanced Life Support parameters (children >1 year to 10 years, systolic blood pressure (SBP)<(70 + 2 x age in years); >10 years, SBP < 90 mmHg)71
- Known severe renal impairment (by parent or patient report)
- Application of assisted ventilation before enrollment assessment (intubated, bi-level positive airway pressure, continuous positive airway pressure)
- Received IVMg within 24 hours prior to screening (by parent or patient report or medical record review)
- Enrollment assessment is 60 minutes after the start of ED treatment (start of first albuterol treatment)
- Previous enrollment in the same trial (by research coordinator review of trial records)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Primary Children's Hospital
Salt Lake City, Utah, 84010
About this study
Official title: Intravenous Magnesium: Prompt Use for Asthma in Children Treated in the Emergency Department
Many children currently being hospitalized with severe asthma could potentially avoid hospitalization and be sent home if their treatment in the emergency department was more effective. The investigators will conduct a pilot trial that will lead to a larger study to conclusively answer whether a simple and inexpensive medicine, intravenous magnesium sulfate, can be used in the emergency department to prevent hospitalization for these children.
Read the detailed description
5.4.1 Acquisition The specific study agent to be used in this pilot trial is Magnesium Sulfate in Water for Injection, a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water. Study agent will be acquired by each hospital's research pharmacy from Pfizer, Inc as a solution of magnesium sulfate in water at 80 mg/mL. Agent will be shipped directly from Pfizer to each study hospital pharmacy.
5.4.2 Preparation, Storage \& Labeling Doses for each IVMg arm will be prepared in identical manner, by drawing a specified volume of Intravenous Magnesium Sulfate (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. 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. 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. Each prepared dose will be labeled according to the sequential randomization scheme and stored according to local pharmacy procedure. Unused doses prepared locally will be replaced after one week of storage.
5.4.3 Dosing Schedule
After randomization the institutional pharmacist will draw equivolumetric dosages (1 mL/kg, with max of 40 mL) from previously prepared vials. Enrolled subjects will be randomized to one of three arms:
- IVMg 75 mg/kg arm: 75 mg/kg (max 3 gm) infused over 20 minutes through a peripheral IV catheter
- IVMg 50 mg/kg arm: 50 mg/kg (max 2 gm) infused over 20 minutes through a peripheral IV catheter
- Placebo arm: 1 mL/kg (max 40 ml) of normal saline over 20 minutes through a peripheral IV catheter 5.4.4 Dose Modification for Potential Toxicity Clinicians will not administer IVMg to enrolled subjects outside of the study protocol until study outcomes have been determined 2 hours after the start of the infusion. The half-life of IVMg is approximately 2 hours.49 Repeated-dose protocols in an ICU setting that gave as much as 125 mg/kg IVMg to children with asthma over two hours produced no hypotension or other serious adverse effects.47 Because of this margin of safety, open-label IVMg 50 mg/kg can be administered safely 2 hours after the study infusion under strict study monitoring protocols without need for unblinding.
- Conditions
- Asthma
- Being tested
- Magnesium Sulfate, Heptahydrate, 0.9% saline
- Keywords
- asthma, IV Magnesium
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate, HeptahydrateDrug
Also called Intravenous magnesium sulfate
A single dose of intravenous magnesium sulfate given over 20 minutes through a peripheral intravenous line. Two arms of the study will deliver intravenous magnesium, one at a dose of 50 mg/kg, and the other at a dose of 75 mg/kg.
0.9% salineDrug
Also called normal saline, 0.9% sodium chloride
A single dose of intravenous 0.9% sodium chloride given over 20 minutes through a peripheral intravenous line as the placebo arm of the study.
| Study group | Role | What they receive |
|---|---|---|
| 75 mg/kg | Active comparator | 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 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. Receives: Drug: Magnesium Sulfate, Heptahydrate |
| 50 mg/kg | Active comparator | 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 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. Receives: Drug: Magnesium Sulfate, Heptahydrate |
| Placebo | Placebo comparator | 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 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. Receives: Drug: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
The primary outcome in this pilot trial is demonstration of the ability to enroll severely ill children with asthma in a randomized trial requiring timely delivery of IVMg or placebo. The investigators anticipate that the primary outcome of the future large trial will be the proportion of children hospitalized at the index visit in each arm.
Measured: 7 months of enrollment.
Secondary outcomes (24)
Hospitalization
Actual patient disposition from medical record review after completion of ED treatment. Hospitalization will be defined as any outcome other than discharge from the ED, including hospitalization in an ICU, hospital unit, or observation area.
Measured: Actual disposition from chart review 1 week after enrollment.
Hospitalization Anticipated by Treating Physician 2 Hours After Start of Study Infusion
The treating clinician's stated disposition two hours after the start of study infusion.
Measured: Physician-anticipated hospitalization 2 hours after the start of study drug infusion
Adverse Events and Safety Profiles - Hypotension and Perfusion
Decrease in blood pressure was categorized based on degree of associated symptoms and defined as occurring less than 2 hours after the start of study drug infusion or 2 hours and later. Hypotension is defined by age-based Pediatric Advanced Life Support guidelines.
Measured: 2 hours after study drug infusion.
Rescue Therapies Used During ED Care - SQ or IM Epinephrine
Count of the number of participants that were administered subcutaneous (SQ) or intramuscular (IM) epinephrine while in the ED during the index visit, recorded by chart review approximately one week after enrollment.
Measured: One week after enrollment
Return ED Visit
In patients discharged from the ED, any ED visit and/or hospitalization following discharge.
Measured: Within 10 days after ED discharge
Baseline Serum Magnesium
Measured: At IV placement before infusion of study drug
Baseline Ionized Magnesium
Measured: At IV placement before infusion of study drug
Post-infusion Serum Magnesium 1
Measured: 20-40 minutes after the start of study drug infusion
Post-infusion Ionized Magnesium 1
Measured: 20-40 minutes after the start of study drug infusion
Post-infusion Serum Magnesium 2
Measured: 90-150 minutes after the start of study drug infusion
Post-infusion Ionized Magnesium 2
Measured: 90-150 minutes after the start of study drug infusion
Rescue Therapies Used During ED Care - IV Epinephrine
Count of the number of participants that were administered intravenous (IV) epinephrine while in the ED during the index visit, recorded by chart review approximately one week after enrollment.
Measured: One week after enrollment
Rescue Therapies Used During ED Care - IV Terbutaline
Count of the number of participants that were administered intravenous (IV) terbutaline while in the ED during the index visit, recorded by chart review approximately one week after enrollment.
Measured: One week after enrollment
Rescue Therapies Used During ED Care - IV Magnesium
Count of the number of participants that were administered intravenous (IV) magnesium while in the ED during the index visit aside from any study infusion administered, recorded by chart review approximately one week after enrollment.
Measured: One week after enrollment
Adverse Events and Safety Profiles - Supraventricular Tachycardia
Adverse events were assessed through chart review and phone call with the parent of the participant one week after enrollment. Timing after start of study infusion was not recorded.
Measured: 1 week
Adverse Events and Safety Profiles - Abdominal Discomfort
Adverse events were assessed through chart review and phone call with the parent of the participant one week after enrollment. Timing after start of study infusion was not recorded.
Measured: 1 week
Adverse Events and Safety Profiles - Vomiting
Adverse events were assessed through chart review and phone call with the parent of the participant one week after enrollment. Timing after start of study infusion was not recorded.
Measured: 1 week
Adverse Events and Safety Profiles - Fatigue
Adverse events were assessed through chart review and phone call with the parent of the participant one week after enrollment. Timing after start of study infusion was not recorded.
Measured: 1 week
Adverse Events and Safety Profiles - Hypokalemia
Adverse events were assessed through chart review and phone call with the parent of the participant one week after enrollment. Timing after start of study infusion was not recorded.
Measured: 1 week
Adverse Events and Safety Profiles - Delirium
Adverse events were assessed through chart review and phone call with the parent of the participant one week after enrollment. Timing after start of study infusion was not recorded.
Measured: 1 week
Adverse Events and Safety Profiles - Hypoxia
Adverse events were assessed through chart review and phone call with the parent of the participant one week after enrollment. Timing after start of study infusion was not recorded.
Measured: 1 week
Adverse Events and Safety Profiles - Respiratory Distress
Adverse events were assessed through chart review and phone call with the parent of the participant one week after enrollment. Timing after start of study infusion was not recorded.
Measured: 1 week
Adverse Events and Safety Profiles - Metabolic Acidosis
Adverse events were assessed through chart review and phone call with the parent of the participant one week after enrollment. Timing after start of study infusion was not recorded.
Measured: 1 week
Adverse Events and Safety Profiles - Duodenal Ulcer Perforation
Adverse events were assessed through chart review and phone call with the parent of the participant one week after enrollment. Timing after start of study infusion was not recorded.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start12 Sep 2022
- Primary completion31 May 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Nationwide Children's Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mike Johnson, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166811
- Sponsor's protocol ID
- IRB 104082
- Other IDs
- 1R34HL152047-01A1
- Acronym
- IMPACT-ED
- Status last verified
- Dec 2024
- First submitted
- 23 Nov 2021
- Last updated
- 18 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Johnson MD, Barney BJ, Rower JE, Finkelstein Y, Zorc JJ. Intravenous Magnesium: Prompt Use for Asthma in Children Treated in the Emergency Department (IMPACT-ED): Protocol for a Multicenter Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 17;12:e48302. doi: 10.2196/48302.
PubMed 37459153
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Magnesium: Prompt Use for Asthma in Children Treated in the Emergency Department
- ClinicalTrials.gov ID
- NCT05166811
- Acronym / sponsor ID
- IMPACT-ED / IRB 104082
- Conditions
- Asthma
- Keywords
- asthma, IV Magnesium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Nationwide Children's Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Posted 18 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many children currently being hospitalized with severe asthma could potentially avoid hospitalization and be sent home if their treatment in the emergency department was more effective. The investigators will conduct a pilot trial that will lead to a larger study to conclusively answer whether a simple and inexpensive medicine, intravenous magnesium sulfate, can be used in the emergency department to prevent hospitalization for these children.
Detailed description
5.4.1 Acquisition The specific study agent to be used in this pilot trial is Magnesium Sulfate in Water for Injection, a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water. Study agent will be acquired by each hospital's research pharmacy from Pfizer, Inc as a solution of magnesium sulfate in water at 80 mg/mL. Agent will be shipped directly from Pfizer to each study hospital pharmacy.
5.4.2 Preparation, Storage \& Labeling Doses for each IVMg arm will be prepared in identical manner, by drawing a specified volume of Intravenous Magnesium Sulfate (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. 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. 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. Each prepared dose will be labeled according to the sequential randomization scheme and stored according to local pharmacy procedure. Unused doses prepared locally will be replaced after one week of storage.
5.4.3 Dosing Schedule
After randomization the institutional pharmacist will draw equivolumetric dosages (1 mL/kg, with max of 40 mL) from previously prepared vials. Enrolled subjects will be randomized to one of three arms:
- IVMg 75 mg/kg arm: 75 mg/kg (max 3 gm) infused over 20 minutes through a peripheral IV catheter
- IVMg 50 mg/kg arm: 50 mg/kg (max 2 gm) infused over 20 minutes through a peripheral IV catheter
- Placebo arm: 1 mL/kg (max 40 ml) of normal saline over 20 minutes through a peripheral IV catheter 5.4.4 Dose Modification for Potential Toxicity Clinicians will not administer IVMg to enrolled subjects outside of the study protocol until study outcomes have been determined 2 hours after the start of the infusion. The half-life of IVMg is approximately 2 hours.49 Repeated-dose protocols in an ICU setting that gave as much as 125 mg/kg IVMg to children with asthma over two hours produced no hypotension or other serious adverse effects.47 Because of this margin of safety, open-label IVMg 50 mg/kg can be administered safely 2 hours after the study infusion under strict study monitoring protocols without need for unblinding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| 75 mg/kg | Active comparator | Drug: Magnesium Sulfate, HeptahydrateDoses 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 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. |
| 50 mg/kg | Active comparator | Drug: Magnesium Sulfate, HeptahydrateDoses 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 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. |
| Placebo | Placebo comparator | Drug: 0.9% salineFor 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 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- A prior physician diagnosis of asthma confirmed by a treating physician in the ED who has spoken with the patient and family and reviewed the medical record (ED attending or fellow physician)
- Severe acute asthma, defined as a Pediatric Respiratory Assessment Measure (PRAM) score of 7 or greater as assessed by a treating physician at the time of screening using the study scoring instrument, which takes 60 seconds to complete
- Children 2-17 years of age
Key exclusion criteria (7 listed)
- Known pregnancy (by patient or parent report) or positive pregnancy test on females 12 years of age and older
- Age-adjusted hypotension at presentation using age-based Pediatric Advanced Life Support parameters (children >1 year to 10 years, systolic blood pressure (SBP)<(70 + 2 x age in years); >10 years, SBP < 90 mmHg)71
- Known severe renal impairment (by parent or patient report)
- Application of assisted ventilation before enrollment assessment (intubated, bi-level positive airway pressure, continuous positive airway pressure)
- Received IVMg within 24 hours prior to screening (by parent or patient report or medical record review)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate, HeptahydrateAlso: Intravenous magnesium sulfateA single dose of intravenous magnesium sulfate given over 20 minutes through a peripheral intravenous line. Two arms of the study will deliver intravenous magnesium, one at a dose of 50 mg/kg, and the other at a dose of 75 mg/kg. | Drug | 50 mg/kg, 75 mg/kg |
| 0.9% salineAlso: normal saline, 0.9% sodium chlorideA single dose of intravenous 0.9% sodium chloride given over 20 minutes through a peripheral intravenous line as the placebo arm of the study. | Drug | Placebo |
Primary outcome
Enrollment
Time frame: 7 months of enrollment.
The primary outcome in this pilot trial is demonstration of the ability to enroll severely ill children with asthma in a randomized trial requiring timely delivery of IVMg or placebo. The investigators anticipate that the primary outcome of the future large trial will be the proportion of children hospitalized at the index visit in each arm.
24 secondary outcomes
Hospitalization
Time frame: Actual disposition from chart review 1 week after enrollment.
Hospitalization Anticipated by Treating Physician 2 Hours After Start of Study Infusion
Time frame: Physician-anticipated hospitalization 2 hours after the start of study drug infusion
Adverse Events and Safety Profiles - Hypotension and Perfusion
Time frame: 2 hours after study drug infusion.
Rescue Therapies Used During ED Care - SQ or IM Epinephrine
Time frame: One week after enrollment
Return ED Visit
Time frame: Within 10 days after ED discharge
Baseline Serum Magnesium
Time frame: At IV placement before infusion of study drug
Baseline Ionized Magnesium
Time frame: At IV placement before infusion of study drug
Post-infusion Serum Magnesium 1
Time frame: 20-40 minutes after the start of study drug infusion
Post-infusion Ionized Magnesium 1
Time frame: 20-40 minutes after the start of study drug infusion
Post-infusion Serum Magnesium 2
Time frame: 90-150 minutes after the start of study drug infusion
Post-infusion Ionized Magnesium 2
Time frame: 90-150 minutes after the start of study drug infusion
Rescue Therapies Used During ED Care - IV Epinephrine
Time frame: One week after enrollment
Rescue Therapies Used During ED Care - IV Terbutaline
Time frame: One week after enrollment
Rescue Therapies Used During ED Care - IV Magnesium
Time frame: One week after enrollment
Adverse Events and Safety Profiles - Supraventricular Tachycardia
Time frame: 1 week
Adverse Events and Safety Profiles - Abdominal Discomfort
Time frame: 1 week
Adverse Events and Safety Profiles - Vomiting
Time frame: 1 week
Adverse Events and Safety Profiles - Fatigue
Time frame: 1 week
Adverse Events and Safety Profiles - Hypokalemia
Time frame: 1 week
Adverse Events and Safety Profiles - Delirium
Time frame: 1 week
Adverse Events and Safety Profiles - Hypoxia
Time frame: 1 week
Adverse Events and Safety Profiles - Respiratory Distress
Time frame: 1 week
Adverse Events and Safety Profiles - Metabolic Acidosis
Time frame: 1 week
Adverse Events and Safety Profiles - Duodenal Ulcer Perforation
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37459153Johnson MD, Barney BJ, Rower JE, Finkelstein Y, Zorc JJ. Intravenous Magnesium: Prompt Use for Asthma in Children Treated in the Emergency Department (IMPACT-ED): Protocol for a Multicenter Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 17;12:e48302. doi: 10.2196/48302.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium Sulfate, Heptahydrate and 0.9% saline in people with Asthma, run by University of Utah at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: 7 months of enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05166811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.