Environmental Exposure to Lead and Its Health Effects on Patients With Maintenance Hemodialysis
Status:
Unknown status
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
One thousand patients with LHD who have no history of exposure to lead will be observed for
18 months. Blood lead level(BLL), biochemical data, hemoglobin, albumin, Cr, high sensitivity
C-reactive protein (HsCRP), and blood cell counts are assessed at baseline. The morbidity and
mortality are recorded in detail. Then, one hundred subjects with high BLL (>20μg/dl) will be
randomly assigned to the study and control groups. For 3-6 months, the 50 patients in the
study group will receive lead-chelation therapy with calcium disodium EDTA weekly until the
BLB falls below BLL< 5 μg/dl, and the 50 control group patients receive weekly placebo for 12
weeks. During the ensuing 18 months, the BLL, biochemical data will be regularly followed up
every 3 months. BLL is measured every 6 months. If BLL of the study group patients increase
>10 μg/dl, the chelation therapy will be performed again until their BLL is <5 μg/dl. The
primary end point is morbidity or mortality during the observation and follow-up period. A
secondary end point is the change in hemoglobin, albumin, Cr and Hs CRP during the follow up
period.