NCT03454906

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
Last Updated

March 6, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

February 2, 2018

Last Update Submit

February 27, 2018

Conditions

Keywords

hemodialysishemoglobin variabilitymortalitynutritioninflammation

Outcome Measures

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

    six month

Study Arms (6)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age \>18
  • on chronic hemodialysis treatment

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Baskent University Nephrology Department

Study Record Dates

First Submitted

February 2, 2018

First Posted

March 6, 2018

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

February 1, 2010

Last Updated

March 6, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share