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

NCT00926406 | Unknown

• 1 other identifier: 96-1455C
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Environmental lead exposure, maintenance hemodialysis; blood lead levels, EDTA chelating agents, malnutrition, anemia, inflammation, mortality.; To determine whether lead chelation therapy improves the anemia, malnutrition, inflammation, morbidity or mortality in hemodialysis patients.

Outcome Measures

Primary Outcomes (1)

• The primary end point is morbidity or mortality during the follow-up period.

  18 months follow-up period

Secondary Outcomes (1)

• A secondary end point is the change in HB, albumin, Cr and Hs CRP during the follow up period.

  18 months follow-up period

Interventions

lead chelation therapy DRUG

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan, 33333, Taiwan

RECRUITING

MeSH Terms

Conditions

Anemia; Malnutrition; Inflammation; Lead Poisoning

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heavy Metal Poisoning; Poisoning; Chemically-Induced Disorders

Central Study Contacts

Ja-Liang Lin, MD

CONTACT

886-3-3281300; jllin@adm.cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 21, 2009
• First Posted: June 23, 2009
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 7, 2010

Record last verified: 2010-04

Locations

TW (1)