PIVOTAL

Dear all

I would be grateful if you could spend a few minutes completing this brief survey to understand whether your unit has implemented the results of the PIVOTAL study which you may have participated in and what percentage of all hemodialysis patients (both prevalent and incident) would be eligible based on the criteria I have highlighted.


As  reminder the inclusion exclusion criteria were

INCLUSION CRITERIA
>18 years
CRP <50
On HD for <1 year (incident)
SF <400
TS <30%
On ESA therapy

EXCLUSION CRITERIA
ALT >x3 normal
Advanced NYHA IV heart failure
Planned Tx in next 12 months
Life expectancy <12 months
Active malignancy
ACTIVE infection
 

And the Proactive regime was
IV iron 600mg in the first month and then 400mg per month – withhold if SF >700 or TS%> 40

Given as 200mg for first 3 sessions on randomization then 200mg on 2 occasions in the next month and then monthly


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* 1. What unit do you work in and were you a PIVOTAL investigator

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* 2. Are you involved in the care of haemodialysis patients

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* 3. which unit do you work in and is iron administered in your unit based on a unit protocol; individualised consultant care or other - please detail

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* 4. Since publication of the PIVOTAL study in the NEJM in 2019 has your unit implemented this protocol for proactive IV iron in your dialysis population.

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* 5. If No please give details of reasons for not implementing

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* 6. If you have implemented the PIVOTAL regime, do you give it to all HD patients – both incident and prevalent

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* 7. Do you follow the protocol as in trial or a modification – please give details

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* 8. What percentage of all your HD patients would not be eligible for the PIVOTAL regime from the following criteria
CRP>50
SF>400
TSAT>40
Active infection - Please give approx % for each of above

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* 9. What would be needed to allow implementation of the PIVOTAL protocol

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* 10. Are any patients excluded – drop down menu (tick all that apply)

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