Environmental Exposure to Lead and Its Health Effects on Patients With Maintenance Hemodialysis

Not Applicable

• Conditions: Anemia; Malnutrition; Inflammation; Lead Poisoning

• Registration Number: NCT00926406
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-21
• Study First Submitted QC: 2009-06-22
• Study First Posted: 2009-06-23
• Status Verified: 2010-04
• Study Start: 2010-04
• Last Update Submitted: 2010-04-05
• Last Update Posted: 2010-04-07
• Primary Completion: 2011-10
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• MHD patients have dialyzed for more than 6 months and age >18 and < 90 year-old

Exclusion Criteria

• Patients with malignancies and obvious infectious diseases as well as those who are hospitalized or underwent surgery or renal transplantation within the 3 months preceding the investigation;Patients with a history of occupational exposure to heavy metals, metal intoxication, living in metal-contaminated areas were also excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary end point is morbidity or mortality during the follow-up period.	18 months follow-up period

Secondary Outcome Measures

Name	Time	Method
A secondary end point is the change in HB, albumin, Cr and Hs CRP during the follow up period.	18 months follow-up period

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan