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

NCT ID: NCT03454906

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 169 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-02-28

Brief 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.

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.

Conditions

Hemodialysis-Induced Symptom

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

L Hemoglobin

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

No interventions assigned to this group

T Hemoglobin

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

No interventions assigned to this group

H Hemoglobin

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

No interventions assigned to this group

LAL Hemoglobin

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

No interventions assigned to this group

LAH Hemoglobin

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

No interventions assigned to this group

HA Hemoglobin

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baskent University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Bal

Baskent University Nephrology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 29805324 (View on PubMed)

Other Identifiers

KA09/358

Identifier Type: -

Identifier Source: org_study_id