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Chemoreflex Sensitivity in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT00794872
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : November 20, 2008
Sponsor:
Collaborators:
Heinrich-Heine University, Duesseldorf
Medical Clinic I, SLK-Kliniken Heilbronn
Information provided by:
RWTH Aachen University

Brief 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.

Condition or disease Intervention/treatment
Chronic Kidney Disease Cardiovascular Morbidity Other: blood sampling

Detailed 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.

Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hyperoxic Chemoreflex Sensitivity in Chronic Kidney Disease
Study Start Date : January 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1
Patients with stage 3 CKD
Other: blood sampling
2
Patients with stage 4 CKD
Other: blood sampling
3
Patients without evidence for CDK
Other: blood sampling



Primary Outcome Measures :
  1. Hyperoxic chemoreflex sensitivity is impaired in patients with moderate to severe chronic kidney disease

Biospecimen Retention:   Samples Without DNA
Measurement of the venous partial pressure of oxygen in blood samples


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794872


Locations
Germany
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Heinrich-Heine University, Duesseldorf
Medical Clinic I, SLK-Kliniken Heilbronn
Investigators
Principal Investigator: Christian Meyer, MD RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

Responsible Party: Christian Meyer, MD, RWTH Aachen University
ClinicalTrials.gov Identifier: NCT00794872     History of Changes
Other Study ID Numbers: Chemoreflex-Sensitivity-Study
First Posted: November 20, 2008    Key Record Dates
Last Update Posted: November 20, 2008
Last Verified: November 2008

Keywords provided by RWTH Aachen University:
Cardiovascular autonomic neuropathy
Chemoreflex sensitivity
Chronic kidney disease
Sudden cardiac arrest

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hypersensitivity
Urologic Diseases
Renal Insufficiency
Immune System Diseases