The purpose of this trial is to compare the safety profile using equal doses of intravenous iron dextran versus iron sucrose. The researchers hypothesize that significantly more patients receiving intravenous iron dextran (using the current intermediate molecular weight product) will have severe adverse outcomes than patients receiving iron sucrose in the adult non-hemodialysis outpatient population. Secondly, since these severe reactions may require additional nursing time and physician interventions that may negate any cost advantage of iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than iron dextran.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
300mg in 250cc normal saline given over 2 hours
300mg in 250cc normal saline given over 2 hours
London Health Sciences Centre
London, Ontario, Canada
Incidence of severe adverse drug reactions (ADRs)
Time frame: Immediate - during infusion
Incidence of serious adverse drug reactions (ADRs)
Time frame: Immediate and delayed - within 24hrs post infusion
Incidence of anaphylactic/anaphylactoid ADRs
Time frame: Immediate - during infusion
Incidence of combined mild and moderate ADRs
Time frame: Immediate - during infusion
Incidence of delayed ADRs
Time frame: delayed - within 24hrs post infusion
Incidence of all-cause mortality
Time frame: Immediate and delayed - within 24hrs post infusion
Physician and nursing time required to manage ADRs
Time frame: Immediate and delayed - within 24hrs post infusion
Response in laboratory parameters
Time frame: Within 1 month
Cost effectiveness
Time frame: Completion of study
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