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

Renal Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227158
• Other study ID #: Uhyogo4
• Status: Completed
• Start date: April 20, 2020
• Est. completion date: August 20, 2020

Study information

• Verified date: March 2020
• Source: University of Hyogo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: August 20, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Anemia

Locations

Country	Name	City	State
Japan	Graduate School of Applied Informatics, University of Hyogo	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
University of Hyogo

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)