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

February 27, 2018 updated by: Zeynep Bal, Baskent University

Baskent University Nephrology Department

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

169

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Age >18
  • on chronic hemodialysis treatment

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors Influencing Hemoglobin Variability and Its Association with Mortality in Hemodialysis Patients
Time Frame: six month
investigation of factors influencing hemoglobin variability with inflammatory and nutritional parameters and the association of hemoglobin variability with all-cause mortality among hemodialysis patients
six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

March 6, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KA09/358

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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