Magnesium in Crisis (MAGiC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Medical College of Wisconsin
Sponsor:
Collaborator:
Pediatric Emergency Care Applied Research Network
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01197417
First received: August 31, 2010
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Sickle Cell Disease
Drug: Intravenous Magnesium Sulfate
Drug: Normal Saline Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Hypotension associated with 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 ] [ Designated as safety issue: Yes ]
    Defined as >20% systolic blood pressure reduction from measurement in the outpatient clinic within the last year while well, when available, or from the median normal blood pressure for age and height

  • Warm sensation associated with 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 ] [ Designated as safety issue: Yes ]
  • Rehospitalization [ Time Frame: Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Functional outcomes and health-related quality of life (HRQL) [ Time Frame: HRQL will be assessed during the 1st study drug infusion, after the last study drug infusion, 8-10 days post discharge, and 1-3 months post discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 208
Study Start Date: December 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnesium group Drug: Intravenous Magnesium Sulfate
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
Placebo Comparator: Placebo group Drug: Normal Saline Placebo
(1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

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.

  Eligibility

Ages Eligible for Study:   4 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 4-21 years, inclusive
  • Hb SS or Hb Sβ° thalassemia disease
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197417

Contacts
Contact: David Brousseau, MD, MS 414-266-2625 dbrousse@mcw.edu

Locations
United States, District of Columbia
Children's National Medical Center Recruiting
Washington DC, District of Columbia, United States, 20010
Contact: Oluwakemi Badaki       OBadaki@childrensnational.org   
Principal Investigator: Oluwakemi Badaki, MD         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Elizabeth Powell       epowell@luriechildrens.org   
Principal Investigator: Elizabeth Powell, MD         
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact: Prashant Mahajan       pmahajan@med.wayne.edu   
Principal Investigator: Prashant Mahajan, MD         
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Julie Leonard       Leonard_Ju@kids.wustl.edu   
Principal Investigator: Julie Leonard, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Research Institute Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Angela Ellison       ELLISONA@email.chop.edu   
Principal Investigator: Angela Ellison, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Robert Hickey       Robert.Hickey@chp.edu   
Principal Investigator: Robert Hickey, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Corrie Chumpitazi       cechumpi@texaschildrens.org   
Principal Investigator: Corrie Chumpitazi, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: David Brousseau, MD, MS    414-266-2625    dbrousse@mcw.edu   
Principal Investigator: David Brousseau, MD, MS         
Sponsors and Collaborators
Medical College of Wisconsin
Pediatric Emergency Care Applied Research Network
Investigators
Principal Investigator: David Brousseau, MD, MS Medical College of Wisconsin
  More Information

No publications provided by Medical College of Wisconsin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01197417     History of Changes
Other Study ID Numbers: PECARN 025
Study First Received: August 31, 2010
Last Updated: July 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical College of Wisconsin:
Sickle Cell Disease
Magnesium Sulfate
Pediatric

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Magnesium Sulfate
Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on October 29, 2014