MAST - Magnesium for Sickle Cell Acute Crisis in Children - Full Text View

Sponsors and Collaborators:	The Hospital for Sick Children The Physicians' Services Incorporated Foundation
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00313963

Purpose

The purpose of this study is to determine if intravenous magnesium sulfate treatment is effective in reducing the length of stay and pain in children with sickle cell disease suffering an acute vaso-occlusive episode.

Condition	Intervention	Phase
Anemia, Sickle Cell	Drug: Magnesium Sulfate Drug: Normal Saline	Phase III

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Anemia Sickle Cell Anemia

Drug Information available for: Magnesium Magnesium sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	MAST - Magnesium for Sickle Cell Acute Crisis in Children

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

Length of stay in the hospital [ Time Frame: Time frame determined by outcome ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction mean daily pain score during an admission for sickle cell pain crisis [ Time Frame: Length of hospital stay ] [ Designated as safety issue: No ]
Adverse events during admission [ Time Frame: Length of hospital stay ] [ Designated as safety issue: Yes ]
Cumulative Narcotic drug required to manage the crises during admission [ Time Frame: Length of hospital stay ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Magnesium Sulfate Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.
2: Placebo Comparator	Drug: Normal Saline Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.

Detailed Description:

Sickle cell disease is a group of complex, chronic disorders characterized by hemolysis, acute vaso-occlusive episodes (crises), unpredictable acute complications that can be life-threatening, and the variable development of chronic organ damage. Administration of magnesium sulfate has the potential to reduce hemolysis since it induces negatively charged chloride ions and water entry to the cell. To date only one non-randomized, non-blinded, single arm study with only 19 children evaluated the effect of magnesium on length of stay in the hospital of children with sickle cell disease.

In this randomized, double blind, two-arm placebo controlled study, children with sickle cell disease admitted for a vaso-occlusive crisis will receive intravenous magnesium sulfate or placebo every 8 hours during their stay in the hospital , along with pain management. We will measure length of stay (LOS), pain, adverse effects, and the total amount of narcotics required for pain control.

Eligibility

Ages Eligible for Study:	4 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Known sickle cell disease
Previous painful crisis resulting in an Emergency Department(ED) visit
Current visit with a chief complaint of pain
Age 4 years - 18 years
Staff ED decides to admit to the hospital
Staff ED decides to start an intravenous line

Exclusion Criteria:

Fever (>38.5C) during the 24 hours prior to visit at triage
Patients transfused within 90 days of study entry
Patients with known renal disease
Patients with known heart block or myocardial damage
Patients who take a magnesium-containing medication or calcium channel blocker on a regular basis
Patients who received anesthetics, cardiac glycosides and neuromuscular blockers during the acute illness in the last 24 hours
Patients or parents unable to communicate in English
Known pregnancy
Known allergy to Magnesium
Admission to the ICU
Enrolment to the study in the last 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313963

Contacts

Contact: Jeremy Friedman, MD

jeremy.friedman@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Ran D Goldman, MD 416 813 5418 ran.goldman@sickkids.ca
Principal Investigator: Ran D Goldman, MD
Sub-Investigator: William Mounstephen, MD
Sub-Investigator: Melanie Kirby, MD
Sub-Investigator: Jeremy N Friedman, MD

Sponsors and Collaborators

The Hospital for Sick Children

The Physicians' Services Incorporated Foundation

Investigators

Principal Investigator:

Jeremy Friedman, MD

The Hospital for Sick Children, Toronto Canada

More Information

Responsible Party:	The Hospital for Sick Children ( Jeremy Friedman/Principal Investigator )
Study ID Numbers:	1000008367
Study First Received:	April 10, 2006
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00313963
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

Anemia, Sickle Cell
Magnesium Sulfate
pediatric

Study placed in the following topic categories:

Calcium, Dietary
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Magnesium Sulfate

Hemoglobinopathies
Anemia
Anemia, Hemolytic
Hemoglobinopathy
Anemia, Sickle Cell

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Calcium Channel Blockers
Reproductive Control Agents
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators

Tocolytic Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009