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Circadian Rhythm in Kidney Transplantation.


- candidate number10125
- NTR NumberNTR2974
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jul-2011
- Secondary IDs210/253 // NL31617.029.10; METc VUmc // ABR number
- Public TitleCircadian Rhythm in Kidney Transplantation.
- Scientific TitleCircadian Rhythm in Kidney Transplantation -01.
- ACRONYMCRIKT-01
- hypothesisIncreasing kidney function by kidney transplantation might improve the circadian rhythms of melatonin concentration, sleep and 24-hour blood pressure profile.
- Healt Condition(s) or Problem(s) studiedSleep disorders, Renal transplant , Circadian rhythm, Ambulatory blood pressure
- Inclusion criteriaKidney 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 criteriaBoth 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 27-apr-2011
- planned closingdate1-mei-2013
- Target number of participants70
- InterventionsThe 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.
- Primary outcomeRecurrence 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 outcome1. Change in subjective and objective sleep parameters;
2. Circadian body temperature;
3. Ambulant blood pressure profile;
4. Quality of life.
- TimepointsKidney 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.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES M. Russcher
- CONTACT for SCIENTIFIC QUERIES M. Russcher
- Sponsor/Initiator VU University Medical Center, Meander Medical Center Amersfoort
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Meander Medical Center Amersfoort
- PublicationsN/A
- Brief summaryMonocentre study, VU University Medical Centre, Amersfoort, The Netherlands.
- Main changes (audit trail)
- RECORD12-jul-2011 - 2-dec-2013


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