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Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis (MAGiC)

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intravenous Magnesium Sulfate
Normal Saline Placebo
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring Sickle Cell Disease, Magnesium Sulfate, Pediatric

Eligibility Criteria

4 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 4-21 years, inclusive
  • Sickle cell anemia (Hb SS) or Sickle beta zero thalassemia disease (Hb Sβ°)
  • failed intravenous opioid pain management in the emergency department prior to the decision to admit the patient
  • admitted to the inpatient unit for sickle cell pain crisis

Exclusion Criteria:

  • patient received more than 12 hours of intravenous pain medication prior to enrollment
  • previous enrollment in this study (only one admission per child is eligible)
  • history of allergy/intolerance to both intravenous morphine and hydromorphone
  • known other cause for pain (avascular necrosis, gall bladder disease, priapism, etc.)
  • patient with greater than 10 admissions for pain crisis in the past year
  • patient maintained on daily opioids or chronic transfusions for chronic sickle cell pain
  • transfusion within the previous two months
  • known kidney or liver failure (elevation of liver function tests does not warrant exclusion)
  • known pulmonary hypertension
  • pregnancy
  • diagnosis of bacterial infection, fever ≥39.5°C, acute chest syndrome, hemodynamic instability or sepsis
  • current oral magnesium supplementation or current enrollment in another therapeutic study protocol
  • previously diagnosed clinical stroke
  • current or planned use of neuromuscular blocker, nifedipine, ritodrine, or terbutaline
  • allergy to magnesium sulfate
  • discharge from an inpatient unit within 72 hours of arrival in the emergency department for the current pain crisis

Sites / Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Johns Hopkins Hospital
  • Children's Hospital of Michigan
  • Nationwide Children's Hospital
  • Children's Hospital of Philadelphia Research Institute
  • University of Pittsburgh
  • Baylor College of Medicine
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Magnesium group

Placebo group

Arm Description

Intravenous Magnesium Sulfate

Normal Saline placebo

Outcomes

Primary Outcome Measures

Hospital Length of Stay (Hours)

Secondary Outcome Measures

Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization
Hypotension Associated With Infusion
For each study drug infusion, systolic blood pressure (SBP) was measured just prior to the start of the infusion and again every 10 minutes until 30 minutes until the end of the infusion. Hypotension was defined as a greater than 20% reduction in SBP relative to corresponding baseline measurement for any study drug infusion.
Warm Sensation Associated With Study Drug Infusion
Patient spontaneously reported feelings of warmth during any study drug infusion.
Rehospitalization
Development of Acute Chest Syndrome (ACS)
Hospital Length of Stay

Full Information

First Posted
August 31, 2010
Last Updated
December 21, 2015
Sponsor
Medical College of Wisconsin
Collaborators
Pediatric Emergency Care Applied Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT01197417
Brief Title
Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis
Acronym
MAGiC
Official Title
Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Pediatric Emergency Care Applied Research Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the safety and efficacy of intravenous magnesium in shortening the duration of a pain crisis and to determine the health-related quality of life and short term outcomes of children treated with intravenous magnesium during an acute pain crisis.
Detailed Description
It is well known that children with sickle cell disease are at risk for acute pain crises. The usual treatment for these pain crises, intravenous fluids and pain medicines such as morphine, has changed little over the past three decades. In a pilot study, the addition of intravenous magnesium to standard therapy decreased length of stay; however, this study was not randomized, not blinded, not placebo-controlled, and not adequately powered to assess safety. We will conduct a multi-center, randomized, double-blind, placebo controlled trial of about 208 children, ages 4-21 years. Patients will be randomized to receive intravenous magnesium sulfate or placebo every 8 hours for a total of 6 doses, or until discharge. Patients will return for a routine clinic visit up to 3 months after discharge for a baseline assessment. Patients will also complete health-related quality of life measures at 4 timepoints throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Sickle Cell Disease, Magnesium Sulfate, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium group
Arm Type
Experimental
Arm Description
Intravenous Magnesium Sulfate
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Normal Saline placebo
Intervention Type
Drug
Intervention Name(s)
Intravenous Magnesium Sulfate
Intervention Description
40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses
Intervention Type
Drug
Intervention Name(s)
Normal Saline Placebo
Intervention Description
(1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses
Primary Outcome Measure Information:
Title
Hospital Length of Stay (Hours)
Time Frame
From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment
Secondary Outcome Measure Information:
Title
Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization
Time Frame
Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment
Title
Hypotension Associated With Infusion
Description
For each study drug infusion, systolic blood pressure (SBP) was measured just prior to the start of the infusion and again every 10 minutes until 30 minutes until the end of the infusion. Hypotension was defined as a greater than 20% reduction in SBP relative to corresponding baseline measurement for any study drug infusion.
Time Frame
Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment
Title
Warm Sensation Associated With Study Drug Infusion
Description
Patient spontaneously reported feelings of warmth during any study drug infusion.
Time Frame
Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment
Title
Rehospitalization
Time Frame
Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge)
Title
Development of Acute Chest Syndrome (ACS)
Time Frame
Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment
Title
Hospital Length of Stay
Time Frame
Start of first study drug infusion to actual hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 4-21 years, inclusive Sickle cell anemia (Hb SS) or Sickle beta zero thalassemia disease (Hb Sβ°) failed intravenous opioid pain management in the emergency department prior to the decision to admit the patient admitted to the inpatient unit for sickle cell pain crisis Exclusion Criteria: patient received more than 12 hours of intravenous pain medication prior to enrollment previous enrollment in this study (only one admission per child is eligible) history of allergy/intolerance to both intravenous morphine and hydromorphone known other cause for pain (avascular necrosis, gall bladder disease, priapism, etc.) patient with greater than 10 admissions for pain crisis in the past year patient maintained on daily opioids or chronic transfusions for chronic sickle cell pain transfusion within the previous two months known kidney or liver failure (elevation of liver function tests does not warrant exclusion) known pulmonary hypertension pregnancy diagnosis of bacterial infection, fever ≥39.5°C, acute chest syndrome, hemodynamic instability or sepsis current oral magnesium supplementation or current enrollment in another therapeutic study protocol previously diagnosed clinical stroke current or planned use of neuromuscular blocker, nifedipine, ritodrine, or terbutaline allergy to magnesium sulfate discharge from an inpatient unit within 72 hours of arrival in the emergency department for the current pain crisis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Brousseau, MD, MS
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Children's Hospital of Philadelphia Research Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26232172
Citation
Brousseau DC, Scott JP, Badaki-Makun O, Darbari DS, Chumpitazi CE, Airewele GE, Ellison AM, Smith-Whitley K, Mahajan P, Sarnaik SA, Casper TC, Cook LJ, Dean JM, Leonard J, Hulbert ML, Powell EC, Liem RI, Hickey R, Krishnamurti L, Hillery CA, Nimmer M, Panepinto JA; Pediatric Emergency Care Applied Research Network (PECARN). A multicenter randomized controlled trial of intravenous magnesium for sickle cell pain crisis in children. Blood. 2015 Oct 1;126(14):1651-7. doi: 10.1182/blood-2015-05-647107. Epub 2015 Jul 31.
Results Reference
result
PubMed Identifier
28606098
Citation
Panepinto JA, Paul Scott J, Badaki-Makun O, Darbari DS, Chumpitazi CE, Airewele GE, Ellison AM, Smith-Whitley K, Mahajan P, Sarnaik SA, Charles Casper T, Cook LJ, Leonard J, Hulbert ML, Powell EC, Liem RI, Hickey R, Krishnamurti L, Hillery CA, Brousseau DC; Pediatric Emergency Care Applied Research Network (PECARN). Determining the longitudinal validity and meaningful differences in HRQL of the PedsQL Sickle Cell Disease Module. Health Qual Life Outcomes. 2017 Jun 12;15(1):124. doi: 10.1186/s12955-017-0700-2.
Results Reference
derived
PubMed Identifier
24443249
Citation
Badaki-Makun O, Scott JP, Panepinto JA, Casper TC, Hillery CA, Dean JM, Brousseau DC; Pediatric Emergency Care Applied Research Network (PECARN) Magnesium in Sickle Cell Crisis (MAGiC) Study Group. Intravenous magnesium for pediatric sickle cell vaso-occlusive crisis: methodological issues of a randomized controlled trial. Pediatr Blood Cancer. 2014 Jun;61(6):1049-54. doi: 10.1002/pbc.24925. Epub 2014 Jan 17.
Results Reference
derived

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Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

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