1. The objective of this pilot study is to investigate if 72 hours 30% calorie restriction + 24 hours of pre-operative fasting has a beneficial effect on post-operative recovery. 2. The perioperative cytokine response in fasting and non-fasting…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde nierdonoren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recovery of the patient postoperative.
Secondary outcome
interleukines, TNF, LDH and high-sensitive CRP, quality of life and fatigue,
cytokine response
Background summary
Organ transplantation is the only long-term curative treatment for patients
with chronic kidney failure. mplementation of live donation ensures
transplantation of a non-diseased organ before the kidney disease progresses to
it*s terminal fase requiring dialysis. This provides a better transplant
function in the acceptor. The Erasmus Medical Centre has one of the biggest
live kidney donating programmes in the Neteherlands. In this programme healthy
volunteers donate their kidney to another person. The post operative recovery
is very important in these healthy volunteers. Using "nutritional
pre-conditioning", by reducing the preoperative intake, we aim to improve the
post operative recovery.
Study objective
1. The objective of this pilot study is to investigate if 72 hours 30% calorie
restriction + 24 hours of pre-operative fasting has a beneficial effect on
post-operative recovery. 2. The perioperative cytokine response in fasting
and non-fasting patients undergoing donor nephrectomy will be investigated.3.
The changes in the insulin/ IGF-1 (somatotroph) pathway will be determined. 4.
Patients VAS,MFI-20, SF-36, EuroQol and work related scores are documented at
regular times to measure postoperative recovery.5. Transcriptional changes
índicative of inflammation in per-operative biopsies of donated kidneys will be
compared between both groups.
Study design
The experimental group will record their nutrition intake during 2 random week
days and one weekend day according to a dietary form. Based on reported calorie
intake patients start a 30% calorie restricted diet three days preoperatively.
The day before surgery the donor is allowed to have a light breakfast followed
by 24 hours of fasting. Until midnight preoperatively they are allowed to drink
water ad libitum.
There is no restriction on the diet of the control group during the
preoperative days. They will also fill in the dietary forms.These patients are
fasted overnight as usual.
Transcriptional changes índicative of inflammation in per-operative biopsies,
obtained through standard procedures, of donated kidneys will be compared
between both groups
Serum creatinine, ureum, glucose, insulin, IGF-1, interleukins, TNF, LDH and
high-sensitive CRP are measured at pre-arranged times: 12 hours preoperatively,
6 hours postoperatively, and daily until discharge.
At three weeks, three months, six months and one year postoperatively donors
are asked to complete forms related to pain, nausea, fatigue, and quality of
life. Preoperatively and at days 1, 3, 7, and 14 the donors score pain and
nausea on a visual analogue scale from 0 (none) to 10 (severe).
To assess whether preoperative energy restriction differentially affects health
related quality of life and fatigue, we use the SF-36 and the multidimensional
fatigue inventory 20 (MFI-20) preoperatively and at 1, 3, 6 months and 1 year
postoperatively.
Intervention
72 hours of dietary restriction followed by 12 extra hours of fasting
pre-operatively during which water is allowed ad libitum. (total 24 hours of
fasting)
Study burden and risks
dietary form
energy reduction
postoperative forms at regular times
Boreelstraat 2b
3039 WK, Rotterdam
Nederland
Boreelstraat 2b
3039 WK, Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
live kidney donors
Exclusion criteria
- Bilateral abnormalities of the renal arteries (origin stenosis)
- Previous operations of the kidney or adrenal gland
- Radiological abnormalities necessitating an open approach
- Peroperative conversion to an open approach.
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 | NL18177.078.07 |