Clinical trial NCT00560976: Serum NGAL Levels in Hemodialysis (HD) Patients; Relation to Iron Status, HD and Intravenous (IV) Iron Administration
Official title: Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels in Hemodialysis (HD) Patients; Relation to Iron Status, Hemodialysis, and Intravenous (IV) Iron Administration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Failure Chronic Requiring Hemodialysis
Keywords: neutrophil gelatinase associated lipocalin
hemodialysis
iron
inflammation
Oxidative Stress
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2007-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess changes in serum levels of the siderophore binding protein NGAL by hemodialysis without and with intravenous iron administration

Detailed description: Serum and urine levels of the siderophore binding protein neutrophil gelatinase associated lipocalin (NGAL) are increased in a number of renal diseases, but has not been evaluated yet in dialysis patients. Since NGAL is suggested to be related to inflammatory processes and iron homeostasis, which are a major problem in dialysis patients, this study aims to assess the relation of serum NGAL levels in hemodialysis (HD) patients to iron status, inflammation, hemodialysis and intravenous(IV) iron administration. Our hypothesis is that serum NGAL levels in HD patients are related to iron status and inflammation and may change following hemodialysis and/or acute or chronic IV iron administration.

The Specific aims are:

1. To assess the relations between basal serum NGAL levels to iron, dialysis, and inflammation related parameters.
2. To assess the effect of HD on serum NGAL levels and their relation with with iron, dialysis and inflammation related parameters.
3. To assess the effects of weekly 100 mg IV iron in the first hour of HD on serum NGAL levels, and the relation of pre IV iron serum NGAL levels with iron, oxidative stress and inflammation related parameters. These assessments will be performed in the first weekly HD.

Eligibility criteria: Inclusion Criteria:

* Chronic hemodialysis patients

Exclusion Criteria:

* Acute disease (infection, thrombosis, ischemia, bleeding)
* Hepatitis B, Hepatitis C or HIV
* Intravenous iron administration or packed red cell transfusion in the last 4 weeks prior to the study

Primary outcomes:
measure: CRP (C-Reactive Protein) and AOPP (Advanced Oxidative Protein Products) Levels
timeFrame: To assess the effects of 100 mg IV iron in the first hour of the first weekly HD on the relation of pre IV iron serum NGAL levels with oxidative stress and inflammation related parameters.
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Department of Nephrology, Soroka University Medical center
city: Haifa
country: Israel
facility: Bnai-zion Medical Center,Nephrology,
city: Holon
country: Israel
facility: Department of Nephrology, Wolfson Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: David Tovbin, MD
role: PRINCIPAL_INVESTIGATOR
References: