Preoperative fasting in combination with a low-dose laxative and postoperative recovery and complications in living kidney donors
Conditions
Interventions
Trade Name: Compound Macrogol Oral Powder Sugar Free
Macrogol 3350
Product Name: Macrogol 3350
Product Code: Generic Product
Pharmaceutical Form: Powder for oral solution in sachet
Sponsors
Erasmus MC, University Medical Center Rotterdam
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A potential subject 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 Another exclusion criterium for participation in this study is the use of double anticoagulants (f.i. Ascal (Carbasalate Calcium) and Clopidogrel (Plavix)) in the recipients (to-be-transplanted).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to determine whether nutritional preconditioning by 2,5 days of fasting and a low dose laxative reduces postoperative fatigue score, 4 weeks after live kidney donation.;Secondary Objective: to assess the feasibility of the fasting diet, possible side effects/burden, duration of postoperative hospital stay, renal function of donor and transplanted patient and the use of urinary extracellular vesicles in renal transplantation.;Primary end point(s): Postoperative fatigue, scored by 36-Item Short Form Health Survey (RAND-36);Timepoint(s) of evaluation of this end point: The primary endpoint will be measured 4 weeks after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Within the first week after live kidney donation, or 4 weeks after surgery.;Secondary end point(s): 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 Physical activity before, during and after hospital stay Postoperative recovery of renal function in the donor Postoperative recovery of renal function in the transplanted patient Determination of upregulation of cytoprotective genes / anti-inflammatory markers Investigate the use and merit of uEV in renal transplantation in human subjects and the effect of fasting on uEV | — |
Countries
Netherlands
Contacts
Public ContactPhD-student/ Physician Researcher
Erasmus MC, University Medical Center Rotterdam
Outcome results
None listed