Safety of a Rapid Infusion Protocol for Administration of Intravenous Iron Polymaltose

This study will assess the immediate (during infusion) and delayed (up to 5 days) adverse events associated with rapid (over 1 hour) administration of intravenous iron polymaltose compared to standard administration (over 6 hours) in patients receiving iron infusions for iron deficiency in a hospital based outpatient setting.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000928910

Acronym

RiFe

Enrollment

116

Registered

2011-08-30

Start date

2011-08-25

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Iron deficiency anaemia is a common problem in the community. While many patients can tolerate oral iron supplements to replenish iron stores and correct the anaemia, a significant minority of patients, either cannot absorb oral iron or have side-effects which preclude its use. These patients are eligible to receive intravenous iron. Guidelines for use of intravenous iron indicate that it should be infused slowly (taking approximately 6 hours). This is inconvenient for patients, takes considerable nursing resource and limits access to outpatient day stay facilities. Anecdotal experience and a recent published paper suggest that intravenous iron can be given much faster (taking approximately 60 min), without undue side-effects. This will be a randomised study between rapid infusion and standard infusion rates of intravenous iron with immediate and delayed side-effects noted. If the rapid infusion rate is well tolerated this would then become the standard of care at the host institution.

Interventions

Intravenous Iron Polymaltose Dose of iron polymaltose will be calculated based on the patients weight and haemoglobin level. A dosing table will be used in line with the organisations current intravenous iron policy. For participants who have been randomised to receive the rapid infusion the maximum dose of iron they will receive will be capped at 1500mg. Rapid intravenous administration over approximately 1 hour. Dose prescribed (up to a maximum of 1500mg) mixed with 250mls of Normal Saline. Commencement of a test dose at a rate of 40mls/hr for 15 minutes. If tolerated the infusion will be increased to a rate of 250mls/hr until the end of the infusion. The rapid infusion differs from the standard in that the volume of normal saline is half and the rate of the infusion will be approximately 1 hour as opposed to the standard rate of approximately 6 hours.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with a confirmed diagnosis of iron deficeincy referred to a hospital based out patients department for intravenous iron infusion.

Exclusion criteria

Pregnancy Class III or IV heart failure. Left ventricular ejection fraction of <30%. Chronic kidney disease with an estimated glomerular filtration rate of <15ml/min. Otherwise deemed at risk of fluid overload. All who do not currently meet the criteria for iron infusion according to current WDHB policy. People who have restricted capability to make independent decisions about their participation in the study i.e. those with known cognitive impairment.

Outcome results