Red Blood Cell Lifespan

Chronic Kidney Disease Clinical Trial

— RBC  

Official title:

Red Blood Cell Lifespan and Inflammation in Dialysis Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01462071
• Other study ID #: 039-08
• Status: Terminated
• Phase: N/A
• First received: October 26, 2011
• Last updated: February 22, 2016
• Start date: May 2008
• Est. completion date: March 2013

Study information

• Verified date: February 2016
• Source: Renal Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Background:

A low amount of red blood cells in the blood of patients with limited kidney function is a well known problem. Besides the lack of substances in the blood like iron or erythropoietin the shortened survival of red blood cells leads to the low red blood cell count. Red blood cells of patients on kidney replacement therapy (dialysis) die earlier than those of healthy persons. They live only about 70 days compared to 120 days in healthy humans. Today little is known about the causes for the shorter survival of the red blood cells in patients on dialysis. Because inflammation leads to a shorter life of the red blood cells in people suffering from several diseases leading to inflammation we would like to learn about the role of inflammation in the shortened life of red blood cells of dialysis patients.

When red blood cells are dying the content is broken down to several substances. One of these substances is the gas carbon monoxide (CO). The carbon monoxide is exhaled with the breath. The more red blood cells die the more CO is exhaled. That's why we can calculate the lifespan of the red blood cells when we measure the amount of CO in breath at the same time as the red blood cell count in the blood.

Aim of the study:

We aim to learn about the influence of inflammation of on red blood cell survival in dialysis patients. To look for factors with effect on inflammation or red blood cell survival, for example type of dialysis access, medication or kind of dialysis treatment.

Study procedures:

Over the course of the 18 month study, 6 observational assessments will take place. If the patient experiences a situation with increased inflammation during the study period (for example any kind of infection or intervention) up to two more study visits will take place. Each study visit will include blood sampling, performed without the need for an extra needle stick, and a breath sampling in order to calculate the red blood survival and to measure markers for inflammation in the blood. The breath sample will be taken using the easy to use GaSampler device developed by a company called Quintron especially for medical breath sampling.

In order to get a sample of air at the patient's home for calculation of carbon monoxide produced in the body we will ask the patients to take home an open empty plastic bottle before each study visit. The bottle should be kept overnight on a table or sideboard in the apartment. Before leaving home for hemodialysis or in clinic visit the patient will seal the plastic bottle with the top, take it to the dialysis center and hand it to the research staff.

Risks:

The amount of the additional blood drawn is 30 ml; this is the amount 2 tablespoons, at each study visit. This does not harm the patient. The breath sampling does not imply any risk.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

Inclusion Criteria:

• Age greater than 18 years

• Chronic hemo- or peritoneal dialysis treatment greater than 3 months

Exclusion Criteria:

• Inability to understand the English language and give informed consent for participation in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hemodialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	Yorkville Dialysis Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Renal Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between inflammation and erythrocyte lifespan		6 visits during 18 month period	No
Secondary	Evaluate the accuracy of HbA1c and fructosamine measurements for assessment of glucose control		6 visits during 18 month period	No