Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R34HL152047-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
| Nationwide Children's Hospital | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate, Heptahydrate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 months of enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Actual disposition from chart review 1 week after enrollment. |
Not provided
Inclusion criteria are:
Exclusion criteria are:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States | ||
| Children's Hospital of Philadelphia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37459153 | Derived | 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. |
Not provided
Not provided
Not provided
The study was conducted at three sites within the Pediatric Emergency Care Applied Research Network (PECARN). The three enrolling sites are EDs at tertiary pediatric hospitals and are geographically and demographically diverse. Eligible participants were identified from children presenting to the ED for treatment of acute asthma. Screening occurred at sites from September 2022 through May 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 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. 0.9% saline: 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. |
| FG001 | 50 mg/kg | Doses for each intravenous magnesium sulfate (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. Magnesium Sulfate, Heptahydrate: A single dose of intravenous magnesium sulfate given over 20 minutes through a peripheral intravenous line. |
| FG002 | 75 mg/kg | Doses for each intravenous magnesium sulfate (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. Magnesium Sulfate, Heptahydrate: A single dose of intravenous magnesium sulfate given over 20 minutes through a peripheral intravenous line. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | For the placebo arm, 40 mL of 0.9% sodium chloride solution was drawn into a polyvinylchloride container identical in appearance to the containers used for the IVMg arms. After randomization the institutional pharmacist prepared the dosage (1 mL/kg, with max of 40 mL) from previously prepared container. The dose was delivered by the clinical nurse over 20 minutes through a peripheral IV. 0.9% saline: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 7 months of enrollment. |
|
Adverse events were evaluated 1 week after enrollment through review of the medical record and phone call with parent of the participant.
No different that expected definitions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | For the placebo arm, 40 mL of 0.9% sodium chloride solution was drawn into a polyvinylchloride container identical in appearance to the containers used for the IVMg arms. After randomization the institutional pharmacist prepared the dosage (1 mL/kg, with max of 40 mL) from previously prepared container. The dose was delivered by the clinical nurse over 20 minutes through a peripheral IV. 0.9% saline: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenal Ulcer Perforation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment | During treatment in the Emergency Department, the patient had persistent severe symptoms. The patient had some improvement of respiratory distress on BiPAP and was transferred to the pediatric ICU. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| supraventricular tachycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael D. Johnson | University of Utah | (801) 935-0503 | mike.johnson@hsc.utah.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2023 | Aug 30, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parental Permission | May 10, 2023 | Aug 16, 2024 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Assent | Jan 4, 2023 | Aug 16, 2024 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
Not provided
Not provided
Randomized, double-blind, placebo-controlled trial
Not provided
Not provided
Doses will be prepared ahead of time by an investigational pharmacist, arms will be identical in appearance, and clinicians administering the study drug will be blinded to the study arm the patient receives.
|
| 0.9% saline | Drug | 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. |
|
|
| 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. |
| 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. | 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. | One week after enrollment |
| Return ED Visit | In patients discharged from the ED, any ED visit and/or hospitalization following discharge. | Within 10 days after ED discharge |
| Baseline Serum Magnesium | At IV placement before infusion of study drug |
| Baseline Ionized Magnesium | At IV placement before infusion of study drug |
| Post-infusion Serum Magnesium 1 | 20-40 minutes after the start of study drug infusion |
| Post-infusion Ionized Magnesium 1 | 20-40 minutes after the start of study drug infusion |
| Post-infusion Serum Magnesium 2 | 90-150 minutes after the start of study drug infusion |
| Post-infusion Ionized Magnesium 2 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1 week |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84010 | United States |
| BG001 | 50 mg/kg | Doses for each IVMg arm were 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 was 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 prepared the dosage (1 mL/kg, with max of 40 mL) from previously prepared container. The dose was delivered by the clinical nurse over 20 minutes through a peripheral IV. Magnesium Sulfate, Heptahydrate: A single dose of intravenous magnesium sulfate given over 20 minutes through a peripheral intravenous line. |
| BG002 | 75 mg/kg | Doses for each IVMg arm were 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 was 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 prepared the dosage (1 mL/kg, with max of 40 mL) from previously prepared container. The dose was by the clinical nurse over 20 minutes through a peripheral IV. Magnesium Sulfate, Heptahydrate: A single dose of intravenous magnesium sulfate given over 20 minutes through a peripheral intravenous line. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Median | Inter-Quartile Range | years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Prior hospitalizations for asthma | Count of Participants | Participants |
|
| ED visit for asthma in the last 12 months | Count of Participants | Participants |
|
| Prescribed a daily controller medication | Count of Participants | Participants |
|
| Taking controller medication 4+ days a week | Count of Participants | Participants |
|
| Personal history of eczema | Count of Participants | Participants |
|
| Personal history of anaphylaxis | Count of Participants | Participants |
|
| Personal history of prematurity | Count of Participants | Participants |
|
| Parent with asthma | Count of Participants | Participants |
|
| Parent with eczema | Count of Participants | Participants |
|
| Parent with seasonal allergies | Count of Participants | Participants |
|
| Arrival pulse oximeter reading 95% or higher | Count of Participants | Participants |
|
| Arrival pulse oximeter reading 92-94% | Count of Participants | Participants |
|
| Arrival pulse oximeter reading 91% or lower | Count of Participants | Participants |
|
| Weight | Median | Inter-Quartile Range | kilograms |
|
| OG001 | 50 mg/kg | Doses for each IVMg arm were 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 was 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 prepared the dosage (1 mL/kg, with max of 40 mL) from previously prepared container. The dose was delivered by the clinical nurse over 20 minutes through a peripheral IV. Magnesium Sulfate, Heptahydrate: A single dose of intravenous magnesium sulfate given over 20 minutes through a peripheral intravenous line. |
| OG002 | 75 mg/kg | Doses for each IVMg arm were 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 was 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 prepared the dosage (1 mL/kg, with max of 40 mL) from previously prepared container. The dose was by the clinical nurse over 20 minutes through a peripheral IV. Magnesium Sulfate, Heptahydrate: A single dose of intravenous magnesium sulfate given over 20 minutes through a peripheral intravenous line. |
|
|
| Secondary | 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. | Participants who were enrolled were included in the intention-to-treat (ITT) population regardless of whether they received study drug according to their randomization arm. | Posted | Count of Participants | Participants | Actual disposition from chart review 1 week after enrollment. |
|
|
|
| Secondary | 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. | Participants who were enrolled were included in the intention-to-treat (ITT) population regardless of whether they received study drug according to their randomization arm. | Posted | Count of Participants | Participants | Physician-anticipated hospitalization 2 hours after the start of study drug infusion |
|
|
|
| Secondary | 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. | Participants in whom the study drug infusion was started were included in the safety population. | Posted | Count of Participants | Participants | 2 hours after study drug infusion. |
|
|
|
| Secondary | 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. | Participants who were enrolled were included in the intention-to-treat (ITT) population for this measure. | Posted | Count of Participants | Participants | One week after enrollment |
|
|
|
| Secondary | Return ED Visit | In patients discharged from the ED, any ED visit and/or hospitalization following discharge. | Participants who were enrolled were included in the intention-to-treat (ITT) population. | Posted | Count of Participants | Participants | Within 10 days after ED discharge |
|
|
|
| Secondary | Baseline Serum Magnesium | Participants in whom the study drug infusion was started were included in the safety population used for these results. | Posted | Mean | Standard Deviation | mg/dL | At IV placement before infusion of study drug |
|
|
|
| Secondary | Baseline Ionized Magnesium | Participants in whom the study drug infusion was started were included in the safety population used for these results. | Posted | Mean | Standard Deviation | mg/dL | At IV placement before infusion of study drug |
|
|
|
| Secondary | Post-infusion Serum Magnesium 1 | Participants in whom the study drug infusion was started were included in the safety population used for these results. | Posted | Mean | Standard Deviation | mg/dL | 20-40 minutes after the start of study drug infusion |
|
|
|
| Secondary | Post-infusion Ionized Magnesium 1 | Participants in whom the study drug infusion was started were included in the safety population used for these results. | Posted | Mean | Standard Deviation | mg/dL | 20-40 minutes after the start of study drug infusion |
|
|
|
| Secondary | Post-infusion Serum Magnesium 2 | Participants in whom the study drug infusion was started were included in the safety population used for these results. | Posted | Mean | Standard Deviation | mg/dL | 90-150 minutes after the start of study drug infusion |
|
|
|
| Secondary | Post-infusion Ionized Magnesium 2 | Participants in whom the study drug infusion was started were included in the safety population used for these results. | Posted | Mean | Standard Deviation | mg/dL | 90-150 minutes after the start of study drug infusion |
|
|
|
| Secondary | 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. | Participants who were enrolled were included in the intention-to-treat (ITT) population for this measure. | Posted | Count of Participants | Participants | One week after enrollment |
|
|
|
| Secondary | 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. | Participants who were enrolled were included in the intention-to-treat (ITT) population for this measure. | Posted | Count of Participants | Participants | One week after enrollment |
|
|
|
| Secondary | 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. | Participants who were enrolled were included in the intention-to-treat (ITT) population for this measure. | Posted | Count of Participants | Participants | One week after enrollment |
|
|
|
| Secondary | 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. | Participants in whom the study drug infusion was started were included in the safety population. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | 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. | Participants in whom the study drug infusion was started were included in the safety population. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | 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. | Participants in whom the study drug infusion was started were included in the safety population. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | 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. | Participants in whom the study drug infusion was started were included in the safety population. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | 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. | Participants in whom the study drug infusion was started were included in the safety population. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | 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. | Participants in whom the study drug infusion was started were included in the safety population. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | 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. | Participants in whom the study drug infusion was started were included in the safety population. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | 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. | Participants in whom the study drug infusion was started were included in the safety population. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | 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. | Participants in whom the study drug infusion was started were included in the safety population. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | 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. | Participants in whom the study drug infusion was started were included in the safety population. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| 0 |
| 18 |
| 2 |
| 18 |
| 4 |
| 18 |
| EG001 | 50 mg/kg | Doses for each IVMg arm were 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 was 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 prepared the dosage (1 mL/kg, with max of 40 mL) from previously prepared container. The dose was delivered by the clinical nurse over 20 minutes through a peripheral IV. Magnesium Sulfate, Heptahydrate: A single dose of intravenous magnesium sulfate given over 20 minutes through a peripheral intravenous line. | 0 | 16 | 0 | 16 | 5 | 16 |
| EG002 | 75 mg/kg | Doses for each IVMg arm were 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 was 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 prepared the dosage (1 mL/kg, with max of 40 mL) from previously prepared container. The dose was by the clinical nurse over 20 minutes through a peripheral IV. Magnesium Sulfate, Heptahydrate: A single dose of intravenous magnesium sulfate given over 20 minutes through a peripheral intravenous line. | 0 | 15 | 0 | 15 | 6 | 15 |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment | The patient had worsening respiratory distress after hospitalization, and was given additional doses of IV mag and was placed on continuous albuterol. |
|
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| hypokalemia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| delirium | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| hypotension | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |
|
| Poor perfusion during hypotension within 2 hours of start of study infusion |
|
| No hypotension measured |
|