Removal of Ligand-bound Iron During Intravenous (IV) Iron Administration in Hemodialysis (HD)

NCT00638300 | Completed

• 1 other identifier: sor421306ctil
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

The study's hypothesis is that HD with large pore dialyzers remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis.

Conditions

Hemodialysis Patients

Keywords

hemodialysis; iron; inflammation; atomic absorption; dialysate; advanced oxidation protein products; large pore dialysate; bicarbonate; calcium; citrate; ligand

Outcome Measures

Primary Outcomes (1)

• 1. Dialysate Iron levels 2. Plasma levels of advanced oxidation protein products(AOPP)

  Before HD, after 1 hour of HD with or without IV iron and at end of HD

Study Arms (6)

1

EXPERIMENTAL

large pore dialyzers (FX80, Fresenius, Germany)

Device: large pore (FX80) compared to small pore dialyzer (F8HPS)

2

EXPERIMENTAL

small pore dialyzers ( F8HPS, Fresenius, Germany)

Device: large pore (FX80) compared to small pore dialyzer (F8HPS)

A

EXPERIMENTAL

dialysate bicarbonate concentration of 33 mEq/l

Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L

B

EXPERIMENTAL

dialysate bicarbonate concentration of 40 mEq/l

Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L

I

EXPERIMENTAL

dialysate calcium concentration of 3 mEq/L

Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L

II

EXPERIMENTAL

dialysate calcium concentration of 2.5 mEq/L

Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L

Interventions

large pore (FX80) compared to small pore dialyzer (F8HPS) DEVICE

Effect of pore size

1; 2

Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L OTHER

Effect of dialysate bicarbonate concentration

A; B

Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L OTHER

Effect of dialysate calcium concentration

I; II

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hemodialysis patients

You may not qualify if:

• Acute disease (infection, thrombosis, ischemia, bleeding) Hepatitis B, Hepatitis C or HIV
• Intravenous iron administration or packed red cell transfusion in the last 3 weeks prior to the study
• Refusal to comply with limitations in fat containing food during HD with plasma sampling for AOPP evaluation

Sponsors & Collaborators

• Soroka University Medical Center: lead
• Bnai Zion Medical Center: collaborator
• Rivka Ziv Medical Center: collaborator

Study Sites (3)

HD unit in Department of Nephrology in Soroka Universty Medical Center

Beersheba, 84101, Israel

Location

HD unit in Bnai-zion Medical Center

Haifa, Israel

Location

Rivka Ziv Medical center

Safed, Israel

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Tovbin, MD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: July 13, 2010

Record last verified: 2008-03

Locations

IL (3)