Chemoreflex Sensitivity in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Hyperoxic Chemoreflex Sensitivity in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794872
• Other study ID #: Chemoreflex-Sensitivity-Study
• Status: Completed
• Phase: N/A
• First received: November 19, 2008
• Last updated: November 19, 2008
• Start date: January 2007
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Cardiovascular morbidity and mortality are markedly increased in chronic kidney disease (CKD) and may be explained in part by sympathetic hyperactivity. Impaired hyperoxic chemoreflex sensitivity (CHRS) has been attributed to an increased sympathetic activity. The aim of the present study is to examine whether chemosensor function is altered in patients with stage 3 and stage 4 CKD.

Description:

Impaired hyperoxic chemoreflex sensitivity (CHRS) is assessed in patients with stage 3 CKD [glomerular filtration rate (GFR) 30-59 ml/min/1.73 m2], in patients with stage 4 CKD [GFR 15-29 ml/min/1.73 m2], as well as in patients without any evidence of CKD. CHRS is measured by determination of the venous partial pressure of oxygen and the heart rate before and after deactivation of the chemoreceptors by inhalation of pure oxygen. The difference in the R-R intervals before and after inhalation divided by the difference in the oxygen pressures is calculated as the CHRS. A CHRS below 3.0 ms/mmHg is defined as pathological. It should be shown that using a simple clinical bedside test we provide the first evidence for impaired hyperoxic chemoreflex sensitivity in stage 3 and 4 chronic kidney disease. We thereby may lay the basis for future intervention studies assessing chemosensor function in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients suffering from CDK stage 3 (GFR 30-59 ml/min/1.73 m²) or stage 4 (GFR 15-29 ml/min/1.73 m²)

• For the reference Patients without evidence for CDK

Exclusion Criteria:

• Patients with heart failure, history of myocardial infarction or instable angina pectoris, atrial fibrillation, hyperthyroidism, chronic pulmonary diseases, sleep apnoea syndrome, alcohol abuse and drug induced cardiomyopathy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Morbidity
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• blood sampling

Locations

Country	Name	City	State
Germany	Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine	Aachen	NRW

Sponsors (3)

Lead Sponsor	Collaborator
RWTH Aachen University	Heinrich-Heine University, Duesseldorf, Medical Clinic I, SLK-Kliniken Heilbronn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperoxic chemoreflex sensitivity is impaired in patients with moderate to severe chronic kidney disease			No