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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00926406
First received: June 21, 2009
Last updated: April 5, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Anemia
Malnutrition
Inflammation
Lead Poisoning
Drug: lead chelation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • The primary end point is morbidity or mortality during the follow-up period. [ Time Frame: 18 months follow-up period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A secondary end point is the change in HB, albumin, Cr and Hs CRP during the follow up period. [ Time Frame: 18 months follow-up period ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926406

Contacts
Contact: Ja-Liang Lin, MD 886-3-3281300 ext 8892 jllin@adm.cgmh.org.tw

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 33333
Contact: Tsang-Tang Hsieh, MD       tth3388@adm.cgmh.org.tw   
Principal Investigator: Ja-Liang Lin, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Institutional Review Board, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00926406     History of Changes
Other Study ID Numbers: 96-1455C
Study First Received: June 21, 2009
Last Updated: April 5, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
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.

Additional relevant MeSH terms:
Anemia
Inflammation
Lead Poisoning
Poisoning
Malnutrition
Hematologic Diseases
Pathologic Processes
Substance-Related Disorders
Nutrition Disorders

ClinicalTrials.gov processed this record on July 22, 2014