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| ID | Type | Description | Link |
|---|---|---|---|
| R-07.03M |
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| Name | Class |
|---|---|
| Stichting Bijstand, Meander Medical Center | UNKNOWN |
| Hoffmann-La Roche | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | MDRD 10-30 | ||
| B | MDRD 30-60 | ||
| C | MDRD 60-80 | ||
| D | MDRD > 80 |
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| Measure | Description | Time Frame |
|---|---|---|
| existence of circadian rhythm of Erythropoietin and Melatonin | 24 hours |
| Measure | Description | 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 |
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Inclusion criteria:
Exclusion criteria:
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Patients with various degrees of renal insufficiency, admitted to Meander Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Carlo AJM Gaillard, MD PhD | Meander Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meander Medical Center | Amersfoort | 3818 ES | Netherlands |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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serum
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |