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CompletedNCT03454906Updated Mar 6, 2018

Factors Influencing Hemoglobin Variability and Its Association With Mortality in Hemodialysis Patients

An observational study in Hemodialysis-Induced Symptom, sponsored by Baskent University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-06.

Sponsored by Baskent University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
169
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to investigate the factors influencing hemoglobin variability with inflammatory and nutritional parameters and its associations with all-cause mortality among hemodialysis patients.

Read the detailed description

Fluctuation in hemoglobin levels that is known as hemoglobin variability during treatment with ESA is a well-documented phenomenon. Several factors have been found to affect hemoglobin variability, including drug related, such as pharmacokinetic parameters, patient-related differences in demographic characteristics and factors affecting clinical status, as well as clinical practice guidelines, treatment protocols and reimbursement policies. Inflammation is also an important factor associated with hemoglobin variability, and the consequences of persistent inflammatory activity are far-reaching in affected patients.

In present study, the factors influencing hemoglobin variability with inflammatory and nutritional parameters and its associations with all-cause mortality among hemodialysis patients are investigated.

02

Conditions studied

  • Hemodialysis-Induced Symptom

Keywords

  • hemodialysis
  • hemoglobin variability
  • mortality
  • nutrition
  • inflammation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

-one hundred and sixty nine patient that receive chronic hemodialysis treatment in Baskent university hospital were enrolled to the study.

Inclusion criteria

  • Age >18
  • on chronic hemodialysis treatment

Exclusion criteria

Exclusion Criteria:

  • All patients had a minimum of six hemoglobin measurements within a 6- month period, and they were excluded if they received a kidney transplant during this period or those who had blood transfusions during the baseline period.
  • Patients with serum ferritin\<100 μg/L were also excluded from the study because of reimbursement of our country.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
169 participants (actual)
Patient registry
No

Groups and cohorts

  • L Hemoglobin

    L Hemoglobin: consistently low all 6 months with low hemoglobin levels

  • T Hemoglobin

    T Hemoglobin; consistently within the target range all 6 months with target-range hemoglobin levels

  • H Hemoglobin

    H Hemoglobin: consistently high all 6 months with high hemoglobin levels

  • LAL Hemoglobin

    LAL Hemoglobin: low amplitude fluctuation with low hemoglobin; all 6 months with low or target range hemoglobin levels

  • LAH Hemoglobin

    LAH Hemoglobin: low-amplitude fluctuation with high hemoglobin levels 6 months with target-range or high hemoglobin levels)

  • HA Hemoglobin

    HA Hemoglobin ; high-amplitude fluctuation low, target-range, and high hemoglobin levels within the 6 month period

05

What researchers measure

Primary outcomes

  1. Factors Influencing Hemoglobin Variability and Its Association with Mortality in Hemodialysis Patients

    investigation of factors influencing hemoglobin variability with inflammatory and nutritional parameters and the association of hemoglobin variability with all-cause mortality among hemodialysis patients

    Time frame: six month

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Bal Z, Demirci BG, Karakose S, Tutal E, Erkmen Uyar M, Acar NO, Sezer S. Factors Influencing Hemoglobin Variability and Its Association with Mortality in Hemodialysis Patients. ScientificWorldJournal. 2018 Apr 1;2018:8065691. doi: 10.1155/2018/8065691. eCollection 2018. PubMed 29805324 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03454906
Lead sponsor
Baskent University
Responsible party
Zeynep Bal (Baskent University Nephrology Department, Baskent University) — Principal investigator
First posted
Mar 6, 2018
Start date
Jan 2009
Primary completion
Jan 2010
Completion
Feb 2010
Last update
Mar 6, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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