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

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.

Study Overview

• Status: Completed
• Conditions: Renal Anemia

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.

• Study Type: Observational
• Enrollment (Actual): 437

Contacts and Locations

Study Locations

• Japan
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0047
      • Graduate School of Applied Informatics, University of Hyogo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients has undergone maintenance Hemodialysis for >1 year.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate between high or low RBC group (all cause death)	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.	three years (retrospectively)

Collaborators and Investigators

• Sponsor: University of Hyogo
• Investigators: Study Director: Yuko MIZUNO, Ph.D., University of Hyogo

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): August 20, 2020
• Study Completion (Actual): August 20, 2020

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: hemoglobin; Hemodialysis patients; red blood cell; mean corpuscular hemoglobin
• Other Study ID Numbers: Uhyogo4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No