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

NCT ID: NCT00926406

Last Updated: 2010-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-12-31

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.

Conditions

Anemia; Malnutrition; Inflammation; Lead Poisoning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

lead chelation therapy

Patients with lead poisoning (BLL\> 20μg/dl) are randomly assigned to a control or chelation group, on the 1:1 proportion. During the 3 months, 50 chelation group patients receive 2-hour weekly intravenous infusions of one vial (1 g) of calcium di-sodium EDTA mixed with 200 ml of normal saline until BLB is BLL \< 5 μg/dl. Fifty control patients receive weekly 2-hour infusions of one vial (20 ml) of 50% glucose mixed with 200 ml of normal saline over a period of 12 weeks9.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taoyuan District, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ja-Liang Lin, MD

Role: CONTACT

jllin@adm.cgmh.org.tw

886-3-3281300 ext. 8892

Facility Contacts

Tsang-Tang Hsieh, MD

Role: primary

tth3388@adm.cgmh.org.tw

Other Identifiers

96-1455C

Identifier Type: -

Identifier Source: org_study_id