MedDataX Logo

MAST - Magnesium for Sickle Cell Acute Crisis in Children

NCT ID: NCT00313963

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia, Sickle Cell

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Anemia, Sickle Cell Magnesium Sulfate pediatric

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.

2

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnesium Sulfate

Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.

Intervention Type DRUG

Normal Saline

Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeremy Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Goldman RD, Mounstephen W, Kirby-Allen M, Friedman JN. Intravenous magnesium sulfate for vaso-occlusive episodes in sickle cell disease. Pediatrics. 2013 Dec;132(6):e1634-41. doi: 10.1542/peds.2013-2065. Epub 2013 Nov 25.

Reference Type DERIVED
PMID: 24276838 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1000008367

Identifier Type: -

Identifier Source: org_study_id