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

The Association Between the Distributions MCH and RBC, and Mortality in a Cohort of Chronic Hemodialysis Patients: a 3-year Retrospective Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04227158

Enrollment

437

Registered

2020-01-13

Start date

2020-04-20

Completion date

2020-08-20

Last updated

2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Anemia

Keywords

red blood cell, mean corpuscular hemoglobin, hemoglobin, Hemodialysis patients

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Survival rate between high or low RBC group (all cause death)	three years (retrospectively)	Survival curves for 3-year survival, based on all available follow-up data, will perform with the use of Kaplan-Meier estimates and will be compared between groups with the use of the log-rank test, and used Holm's method as post hoc.

Countries

Japan

Outcome results