Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

NCT01197417 | Completed Phase 2 Results DMC

• 1 other identifier: PECARN 025
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 8

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.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Magnesium Sulfate; Pediatric

Outcome Measures

Primary Outcomes (1)

• Hospital Length of Stay (Hours)

  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 Outcomes (6)

• Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization

  Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment

• Hypotension Associated With Infusion

  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

• Warm Sensation Associated With Study Drug Infusion

  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

• Rehospitalization

  Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge)

• Development of Acute Chest Syndrome (ACS)

  Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment

Study Arms (2)

Magnesium group

EXPERIMENTAL

Intravenous Magnesium Sulfate

Drug: Intravenous Magnesium Sulfate

Placebo group

PLACEBO COMPARATOR

Normal Saline placebo

Drug: Normal Saline Placebo

Interventions

Intravenous Magnesium Sulfate DRUG

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

Magnesium group

Normal Saline Placebo DRUG

(1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Placebo group

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Pediatric Emergency Care Applied Research Network: collaborator

Study Sites (8)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia Research Institute

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• 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.

  PMID: 26232172 RESULT

• 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.

  PMID: 28606098 DERIVED

• 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.

  PMID: 24443249 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: David Brousseau MD, MS
• Organization: Medical College of Wisconsin

dbrousse@mcw.edu

414-266-2625

Study Officials

• David Brousseau, MD, MS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 9, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 27, 2016
• Results First Posted: September 7, 2015

Record last verified: 2015-12

Locations

US (8)