No registrations found.
ID
Source
Brief title
Health condition
kidney transplantation
circadian rhythm
sleep disturbances
ambulatory blood pressure
Dutch: niertransplantatie, circadiane ritmiek, slaapstoornissen, 24u-bloeddruk
Sponsors and support
Meander Medical Centre, Amersfoort, The Netherlands
Meander Medical Centre, Amersfoort, The Netherlands
Intervention
Outcome measures
Primary outcome
Recurrence of the 'dim light melatonin onset' (DLMO) after kidney transplantation in kidney transplant recipients. Definition of the DLMO: melatonin concentration peak >4 pg/ml saliva, between 7 and 12 pm.
Secondary outcome
1. Change in subjective and objective sleep parameters;
2. Circadian body temperature;
3. Ambulant blood pressure profile;
4. Quality of life.
Background summary
Monocentre study, VU University Medical Centre, Amersfoort, The Netherlands.
Study objective
Increasing kidney function by kidney transplantation might improve the circadian rhythms of melatonin concentration, sleep and 24-hour blood pressure profile.
Study design
Kidney recipients:
1. DLMO (salivary melatonin concentration), ESS (subjective sleep), actigraphy (objective sleep): measured at baseline, 14 days after Tx and 3 months after Tx;
2. MOS-SF36, 24-hour body temperature and 24-hour ambulatory blood pressure measurement are taken at baseline and 3 months after Tx.
Kidney donors:
1. DLMO (salivary melatonin concentration), ESS (subjective sleep), actigraphy (objective sleep), MOS-SF36, 24-hour body temperature and 24-hour ambulatory blood pressure measurement are taken at baseline and 3 months after Tx.
Intervention
The course of the circadian rhythms of melatonin, ambulatory blood pressure, body temperature and sleep are measured in kidney transplant recipients and their living kidney donors before and after kidney transplantation (Tx). A sleep questionnaire (Epworth Sleepiness Scale, ESS) and quality of life questionnaire (MOS-SF36) are taken at baseline and after transplantation.
dept. Hospital Pharmacy<br>
PO Box 1502
M. Russcher
Amersfoort 3800 BM
The Netherlands
+31 (0)33 8501720
M.Russcher@meandermc.nl
dept. Hospital Pharmacy<br>
PO Box 1502
M. Russcher
Amersfoort 3800 BM
The Netherlands
+31 (0)33 8501720
M.Russcher@meandermc.nl
Inclusion criteria
Kidney recipients:
1. Aged 18-85 yr, both male and female;
2. Living donor transplantation;
3. Good understanding of dutch language;
4. Informed consent.
Kidney donors:
1. Aged 18-85 yr, both male and female;
2. Good understanding of dutch language;
3. Informed consent.
Exclusion criteria
Both recipients and donors:
1. Use of hypnotics/melatonin during study measurements;
2. Relevant co-morbidity that interferes with participation in the study according to the investigators (e.g. heart failure NYHA class IV, instable AP, pulmonary, psychiatric, neurologic, blindness);
3. Documented sleep apnea;
4. Alcohol / drug abuse.
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 |
|---|---|
| NTR-new | NL2833 |
| NTR-old | NTR2974 |
| Other | METc VUmc // ABR number : 210/253 // NL31617.029.10; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |