The Association Between the Distributions MCH and RBC, and Mortality in Hemodialysis Patients

NCT ID: NCT04227158

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

437 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-20

Study Completion Date

2020-08-20

Brief Summary

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Patients were classified into two groups based on the values of MCH and RBC, patients with MCH ≥30 pg but \<35 pg and RBC ≤350×104/μL; and MCH \<30 pg and RBC \>350×104/μL. Associations between all-cause mortality and the distributions of MCH and RBC were assessed by Kaplan-Meier curves and Cox proportional hazards regression model.

Detailed Description

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The Hb levels generally provides the value of RBC and iron status because mean corpuscular hemoglobin MCH is derived from the Hb divided by RBC. MCH depends on the size and concentration of erythrocytes. Thus, the value of RBC and MCH depend on dose of ESA and iron, respectively. Guidelines for Renal Anemia in Chronic Kidney Disease of 2015 Japanese Society for Dialysis Therapy recommend administration hemoglobin (Hb) levels ≥10 g/dL but \<12 g/dL in dialysis patients.Patients whose Hb levels is maintained at 10 to 12 g/dL, Hb levels is widely distributed when divided into RBC and MCH. Therefore, the investigators examined the prognosis of life in the distribution of MCH and RBC.

Conditions

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Renal Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients will be controlled with hemoglobin levels between ≥10 g/dL and \<12 g/dL and had undergone maintenance HD for \>1 year.

Exclusion Criteria

* Patients will be excluded if they have peritoneal dialysis combined with HD, do not have records of laboratory investigations during this period, or are transferred to another hospital or lost to follow-up.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hyogo

OTHER

Sponsor Role lead

Responsible Party

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Yoshihiro Tsuji

visiting researche, Yoshihiro Tsuji

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuko MIZUNO, Ph.D.

Role: STUDY_DIRECTOR

University of Hyogo

Locations

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Graduate School of Applied Informatics, University of Hyogo

Kobe, Hyōgo, Japan

Site Status

Countries

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Japan

Other Identifiers

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Uhyogo4

Identifier Type: -

Identifier Source: org_study_id