Chronic Kidney Disease
Conditions
Keywords
chronic kidney disease, melatonin, erythropoietin, circadian rhythm
Brief summary
Rationale: Investigation of the circadian rhythm of erythropoietin and melatonin in patients with various degrees of renal insufficiency Objectives: Primary objective: Is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency? Primary Objective: Is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency compared to patients with a normal renal function? Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various degrees of renal insufficiency? Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various degrees of renal insufficiency compared to patients with a normal renal function? Study design: Comparative study in 4 groups with various degrees of renal insufficiency, duration for each patient 24 hrs. Total duration of study 12 months, patients admitted to the hospital (on nursing ward) Study population: Patients with various degrees of renal insufficiency Main study parameters/endpoints: Analysis of the existence of a circadian rhythm in patients with a normal renal function and in patients with variable degrees of renal insufficiency Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Better knowledge of the circadian rhythm in renal insufficiency. This could lead to a more efficient administration of erythropoietin and melatonin in the future. Extent of burden is 1 venapunction for placement of infusion needle, the withdrawal of 11 times 5 ml blood in 24 hrs, continuous measurement of body temperature via capsule, 24-hour continuous ambulant blood pressure monitoring.
Interventions
None listed
Sponsors
Stichting Bijstand, Meander Medical Center
Hoffmann-La Roche
Meander Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient with various degrees of renal insufficiency, stable creatinin clearance: minimum 10 ml/min (measured with MDRD), admitted to our hospital * Informed Consent * Man/Women between 18 and 85 years * Understanding and knowledge of the dutch language
Exclusion criteria
* Instable angina pectoris, heart failure NYHA class IV * Therapy with erythropoetin, melatonin and hypnotics * Acute renal failure or rapidly progressive glomerulonephritis * Bleeding or hemolysis as a cause of anemia * Deficiency of iron, folate and/or vitamin B12 * Presence of chronic inflammatory disease or clinically significant infection * Hemoglobinopathies * Alcohol and/or drug abuse * Enrolment in another study * Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| existence of circadian rhythm of Erythropoietin and Melatonin | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| existence of a circadian rhythm of cortisol and IGF-1 | 24 hours |
| Relationship between temperature and melatonin. Relationship between blood pressure and erythropoietin | 24 hours |
Countries
Netherlands
Outcome results
None listed