Chemoreflex Sensitivity in Chronic Kidney Disease
| Tracking Information | |||||
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| First Received Date ICMJE | November 19, 2008 | ||||
| Last Updated Date | November 19, 2008 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Hyperoxic chemoreflex sensitivity is impaired in patients with moderate to severe chronic kidney disease [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Chemoreflex Sensitivity in Chronic Kidney Disease | ||||
| Official Title ICMJE | Hyperoxic Chemoreflex Sensitivity in Chronic Kidney Disease | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Measurement of the venous partial pressure of oxygen in blood samples |
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| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Other: blood sampling | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 65 | ||||
| Completion Date | November 2008 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00794872 | ||||
| Other Study ID Numbers ICMJE | Chemoreflex-Sensitivity-Study | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Christian Meyer, MD, RWTH Aachen University | ||||
| Study Sponsor ICMJE | RWTH Aachen University | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | RWTH Aachen University | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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