Discussion
thrombosis
THROMBOSIS, HAND INFECTION, CHRONIC BLOOD LOSS, ADVERSE EVENTS, EVENT, ADVERSE EFFECTS, EVENTS, OXIDATIVE STRESS
Our study shows that maintenance IV iron at higher doses (200 mg vs. 100 mg) was more effective in reducing ESA doses at month 12. However, the incidence of absolute IDA was significantly higher in the 100-mg IV iron group. Nevertheless, iron therapy was withheld significantly more often in the 200-mg IV iron group. There were more adverse effects in access thrombosis, hospitalization, and infection in the 200-mg IV iron group, without statistical significance.Maintenance IV iron in incident hemodialysis patients has been previously studied. As mentioned, the PIVOTAL trialSusantitaphong et al.Theoretically, the appropriate dose of iron supplementation should be equivalent to iron loss. In hemodialysis patients, losing residual blood in the circuit and chronic blood loss in the gastrointestinal tract are the significant causes of iron loss, approximately 1–3 g per year and equivalent to 83–250 mg per monthAnother observational study, using 58,058 hemodialysis patients from DaVita dialysis clinics, showed that IV iron > 400 mg per month was associated with higher all-cause and cardiovascular mortality ratesSafety is always an essential consideration in prescribing iron. IV iron may increase oxidative stress and lead to cardiovascular and infectious complicationsAdditionally, the withholding rates in our study were up to 25% and 64% in 100-mg and 200-mg IV iron. After performing subgroup analysis, baseline ferritin ≥ 364 ng/dl was significantly associated with withholding event. Therefore, in patients with high baseline ferritin levels, we suggest trying 100-mg IV iron first and promptly increasing the dose if the ferritin level does not increase appropriately. This may be less risky than starting with a fixed dose of 200 mg.To our knowledge, this is the first clinical trial of fixed-dose protocol maintenance IV iron. The strength of our study was a randomized, double-blinded, controlled trial, which minimized confounding and other bias relatively well. Secondly, our iron protocol was simple and easy to comply with. However, there were many limitations. First, this study was conducted at a single center, affecting generalizability. Second, the study population was relatively small, and our follow-up period was limited to 12 months. We cannot conclude the impact of the protocol on cardiovascular outcomes and critical adverse events, such as thrombosis and infection. Third, the actual monthly doses (174 and 116 mg) were different from the protocol because of the high withholding rate in the 200-mg group and the high rate of IDA in the 100-mg group, representing that fixed-dose is not fit for all patients. Fourth, clinicians could recognize when rescue iron therapy or withholding events occurred so that ESA dose adjustment may be affected.A maintenance IV iron regimen of 200 mg per month was more effective than the 100-mg dose to minimize ESA doses in hemodialysis patients. Nonetheless, the iron withholding rate was higher. The stepping-up protocol may be an appropriate option in patients with high baseline ferritin if within safety parameters.