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

Primary Purpose

Anemia, Malnutrition, Inflammation

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
lead chelation therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring 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.

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 21, 2009
Last Updated
April 5, 2010
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00926406
Brief Title
Environmental Exposure to Lead and Its Health Effects on Patients With Maintenance Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lead chelation therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary end point is morbidity or mortality during the follow-up period.
Time Frame
18 months follow-up period
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ja-Liang Lin, MD
Phone
886-3-3281300
Ext
8892
Email
jllin@adm.cgmh.org.tw
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsang-Tang Hsieh, MD
Email
tth3388@adm.cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Ja-Liang Lin, MD

12. IPD Sharing Statement

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

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