No registrations found.
ID
Source
Brief title
Health condition
Dietary restriction, Preoperative nutrition, Acute phase response, Surgery
Preoperative voeding, Dieet, Acute fase reactie, operatie
Sponsors and support
Erasmus MC
Dr. Molewaterplein 50
3015 Ge Rotterdam
010-7043683
Intervention
Outcome measures
Primary outcome
Postoperative course of CRP, IL-6, IL-8 and IL-10.
This is an pilot study and therefore no samplesize calculation is performed.
Secondary outcome
Preoperatively and at days 1,2,3,7 and 14 the donors score pain and nausea on a visual analogue scale from 0 (none) to 10 (severe) and report the ability to perform daily tasks in the euroQol questionnaire.
Preoperatively and at 1,3,6 and 12 months postoperatively donors are asked to complete forms related to the quality of life and the ability to perform daily tasks and (if applicable) the time of regaining working activities.
Background summary
N/A
Study objective
Multiple studies have shown that dietary restriction extends lifespan in different animal species ranging from worms to rats. The beneficial effect of calorie restriction on life span may function in part through its ability to increase stress resistance.We hypothesize that the mechanisms involved in extended longevity may also be tapped for short-term clinical benefits against acute stress such as the acute phase response after surgery.
Study design
Preoperatively and at days 1,2,3 and 4 the donors blood samples will be collected and analyzed.
Preoperatively and at 1,3,6 and 12 months postoperatively donors are asked to complete forms related to the quality of life and the ability to perform daily tasks and (if applicable) the time of regaining working activities.
Intervention
Based on reported calorie intake patients randomized to the dietary restriction group start a 30% calorie restricted diet three days pre-operatively. The day before surgery the donor is allowed to have a light breakfast followed by 12 hours of fasting. Until midnight preoperatively they are allowed to drink water ad libitum.
PO Box 2040
J.N.M. IJzermans
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033727
j.ijzermans@erasmusmc.nl
PO Box 2040
J.N.M. IJzermans
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033727
j.ijzermans@erasmusmc.nl
Inclusion criteria
1. Scheduled for laparoscopic donor nephrectomy;
2. 18 years ¡Ü age ¡Ü 80 years;
3. BMI ¡Ý 18.5.
Exclusion criteria
If inclusion criteria are not met.
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 | NL1765 |
| NTR-old | NTR1875 |
| Other | METC Erasmus MC : METC-2007-1999 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |