The primary objective is to determine the effect of nutritional preconditioning by fasting with a lowdose laxative on the severity of postoperative fatigue at 4 weeks after donor nephrectomy in adult patients.
ID
Source
Brief title
Condition
- Other condition
- Renal disorders (excl nephropathies)
- Renal and urinary tract therapeutic procedures
Synonym
Health condition
Upregulatie van beschermende cytokinen tegen oxidatieve schade tgv dieetrestrictie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative fatigue, scored by 36-Item Short Form Health Survey (RAND-36).
The primary endpoint will be measured 4 weeks after surgery.
Secondary outcome
Postoperative fatigue, measured by QoR-40, scored 4 weeks after surgery.
Postoperative hospital admission time, measured in days since surgery.
Adherence to the fasting regime
- Self-reported adherence
- Change of body weight
- Blood samples on the day of surgery
Physical activity before, during and after hospital stay
- Determined by SmartWatches, 1 week prior and 2 weeks after surgery.
Postoperative recovery of renal function in the donor
- Change in Creatinine, Cystatine C, Urea, protein content in urine, and renal
function (eGFR by Cockcroft/CKD-EPI)
-
Postoperative recovery of renal function in the transplanted patient
- Change in Creatinine, Cystatine C, Urea, protein content in urine, and renal
function (eGFR by Cockcroft/CKD-EPI)
- Incidence of delayed graft function (defined as the need of dialysis in 1
week after transplantation)
- Incidence of acute rejection, biopsy proven
Determination of upregulation of cytoprotective genes / anti-inflammatory
markers
- Lab testing, blood samples drawn on day 0
- Kidney biopsy, acquired after donation and after reperfusion
- Tissue retrieval of distal ureter and peri-renal fat
Investigate the use and merit of uEV in renal transplantation in human subjects
and the effect of fasting on uEV
- Assess the change in uEV between fasted en non-fasted subjects
- Assess the correlation between uEV, histopathological changes and
postoperative renal function
- Investigate the use of urinary extracellular vesicles as a predictive
biomarker of future graft function
To assess the effect of fasting on immune cells in the blood (e.g. higher/lower
quantity of immune cells, more/less activation,maturation or differentiation of
those cells)
Study if the immune-modulating effect of fasting correlates with post-operative
recovery of kidney donors.
Background summary
Enhanced Recovery After Surgery (ERAS) reduces both hospital stay and
complication rates. Part of the ERAS protocol consist of early postoperative
mobilization and ad libitum diet. However, no clear recommendation of a
preoperative diet has been made. Further research should be conducted to
improve the recovery time and lessen postoperative fatigue, one of the main
postoperative effectors on donor quality of life (QoL).
Dietary restriction (DR and intermittent fasting are associated with extended
life span, lower risk of age associated diseases, improved fitness and
increased resistance to acute stress. DR and fasting represent non-invasive,
non-expensive methods of mitigating the effects of acute surgery-induced
stress. Short-term dietary restriction and fasting increases expression of
cytoprotective genes, increases immunomodulation via increased
anti-inflammatory cytokine production and also decreases the expression of
pro-inflammatory markers. DR has been proven feasible and safe in
well-nourished patients before live kidney donation. A recent study shows the
beneficial effect of DR on disease control of acromegaly patients.
Dietary restriction can be performed in different regimens. For long term DR
subjects can reduce their daily energy intake with 30% for several weeks or
longer. Another regimen is a short water-only fasting, triggering the same
protective effect . The use of laxatives might affect the timing of the
protective effect of fasting. Live kidney donors are an excellent study
population to further investigate the beneficial effect of preoperative
preconditioning by fasting. Recent studies proved the feasibility of short-term
DR and its merits. To investigate whether the beneficial effect of preoperative
fasting reduces the postoperative fatigue after live kidney donation, a larger
randomized clinical trial is needed. This research is needed since
postoperative fatigue is one of the main effectors on donor quality of life
(QoL).
Study objective
The primary objective is to determine the effect of nutritional preconditioning
by fasting with a lowdose laxative on the severity of postoperative fatigue at
4 weeks after donor nephrectomy in adult patients.
Study design
a multicenter randomized controlled trial.
- Group 1: Control group, no change in diet.
- Group 2: Intervention group: preoperative fasting for 2,5 days and low dose
laxatives once daily
Intervention
Preoperative nutritional preconditioning by a 2,5 day fast, with the use of a
low dose laxatives.
60 hours before surgery (2,5 days), subjects start a fasting regime. Fasting is
defined as no caloric intake. Subjects are free to drink unlimited water, tea
and coffee (without sugar or milk) to maintain a sufficient fluid balance. In
addition, they are allowed a daily dose of 100 grams of vegetables (cucumber,
baby carrots and baby tomatoes). To prevent the loss of electrolytes they are
allowed 3 *Drinkbouillon* (Knorr Tuinkruiden: 3,6 grams per cup, containing
4kcals) or *Opkikkertjes* (Maggi: 3,3 grams per cup , containing 7 kcals).
After surgery, the subjects are free to eat what and how much they want.
Participants in the intervention group also use 1 dose of Macrogol 3350 (13,1
grams and electrolytes) each day for 3 days before surgery.
Study burden and risks
The extent of the burden of our study is considered relatively low. Dietary
restriction has been proven feasible and safe in previous studies. For this
study, extra blood samples are taken at a regular invasive procedure, besides
the samples taken for routine procedures. If a patient takes part in the
additional substudy, additional blood samples will be taken. A maximum of 2
additional venous punctures are necessary. A maximum of one extra visit to the
hospital is needed in order to obtain all the information required for this
study. Peri-operatively, biopsies of the kidney are also taken. The
perioperative biopsies have been shown to carry no to very little risk. Several
standardized questionnaires are asked to be filled in before, during and after
the diet. Mentioned questionnaires take 2-10 minutes to complete. The diet may
give rise to discomfort in the form of less satiety and possible
light-headedness. No other risks concerning the dietary intervention is to be
expected.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Adult patients and donors opting for living kidney donation and transplantation
at Erasmus MC, University Medical Center in Rotterdam, the Netherlands and
University Medical Center Groningen in Groningen, the Netherlands
In order to be eligible to participate in this study, a subject going for live
kidney donation must meet all of the following criteria:
- Age between 18 and 70 years old
- BMI between 19 and 35 kg/m2
- Provide written consent
- Adequate understanding of the Dutch language
Exclusion criteria
A potential subject (Donor) who meets any of the following criteria will be
excluded from participation in this study:
- Participants of the cross-over kidney donation program
- Participation in another prospective trial/study for live kidney donors
- HLA- or bloodtype-incompatible living kidney donation
A potential subject (Recipient) who meets any of the following criteria will be
excluded from participation in this study:
- the use of double anticoagulants (f.i. Ascal (Carbasalate Calcium) and
Clopidogrel (Plavix)).
- the need for therapeutic anticoagulation with low-molecular weight heparine
during admission for kidney transplantation, also known as *Bridging*.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2020-005445-16-NL |
| CCMO | NL74623.078.21 |