Primary objective: Is there a similar circadian rhythm of epo and melatonin in patients with the same degrees of renal insufficiency?Primary Objective: Is there a similar circadian rhythm of epo and melatonin in patients with various degree of renal…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Analysis of the existence of a circadian rhythm in patients with a normal renal
function and in patients with variable degrees of renal insufficiency
Secondary outcome
not applicable
Background summary
Many biological processes in our body follow a 24 hours (= circadian rhythm),
for example the sleep wake rhythm. This study focuses on the circadian rhythm
and the disruption of these rhythm due to renal failure. Erythropoietin (epo)
and melatonin are analyzed in serum and saliva. Dependent on the results of
this study part two of the CREAM can be started, in which variable times of
adminstration of epo could lead to more efficient use of epo (less costs and
more patient friendly). This research is a novelty in its kind.
Study objective
Primary objective: Is there a similar circadian rhythm of epo and melatonin in
patients with the same degrees of renal insufficiency?
Primary Objective: Is there a similar circadian rhythm of epo and melatonin in
patients with various degree of renal insufficiency compared to patients with a
normal renal function?
Secondary Objective: Is there a similar circadian rhythm of cortisol and IGF in
patients with the same degrees of renal insufficiency??
Secondary Objective: Is there a similar circadian rhythm of cortisol and IGF in
patients with various degree 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 6 months, patients
admitted to the hospital (on nursing ward)
Study burden and risks
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 12 times 5 ml blood in 24 hrs, 12 times 1 minute chewing on
cotton plug and measurement of body temperature (12 times)
Postbus 1502
3800 BM Amersfoort
Nederland
Postbus 1502
3800 BM Amersfoort
Nederland
Listed location countries
Age
Inclusion criteria
o Patient with various degrees of renal insufficiency, creatinin clearance: minimum 10 ml/min (measured with MDRD), admitted in our hospital
o Informed Consent
o Man/Women between 18 and 85 years
o Understanding and knowledge of the dutch language
Exclusion criteria
o Instable angina pectoris, heart failure NYHA class IV
o Therapy with erythropoetin, melatonin or/and hypnotics
o Acute renal failure or rapidly progressive glomerulonephritis
o Bleeding or haemolysis as a cause of anaemia
o Deficiency of iron, folate and/or vitamin B12
o Presence of chronic inflammatory disease or clinically significant infection
o Haemoglobinopathies
o Alcohol and/or drug abuse
o Enrolment in another study
o Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16632.100.07 |