Abstract
Background: One of the main effectors on the quality of life of living-kidney donors is postoperative fatigue. Caloric restriction (CR) and short-term fasting (STF) are associated with improved fitness and increased resistance to acute stress. CR/STF increases the expression of cytoprotective genes, increases immunomodulation via increased anti-inflammatory cytokine production, and decreases the expression of pro-inflammatory markers. As such, nutritional preconditioning by CR or STF represents a non-invasive and cost-effective method that could mitigate the effects of acute surgery-induced stress and postoperative fatigue. To investigate whether preoperative STF contributes to a reduction in fatigue after living-kidney donation, a randomized clinical trial is indicated. Methods: We aim to determine whether 2.5 days of fasting reduces postoperative fatigue score in subjects undergoing living-kidney donation. In this randomized study, the intervention group will follow a preoperative fasting regime for 2.5 days with a low-dose laxative, while the control group will receive standard care. The main study endpoint is postoperative fatigue, 4 weeks after living-kidney donation. Secondary endpoints include the effect of preoperative fasting on postoperative hospital admission time, the feasibility of STF, and the postoperative recovery of donor and recipient kidney function. This study will provide us with knowledge of the feasibility of STF and confirm its effect on postoperative recovery. Discussion: Our study will provide clinically relevant information on the merits of caloric restriction for living-kidney donors and recipients. We expect to reduce the postoperative fatigue in living-kidney donors and improve the postoperative recovery of living-kidney recipients. It will provide evidence on the clinical merits and potential caveats of preoperative dietary interventions. Trial registration: Netherlands Trial Register NL9262. EudraCT 2020-005445-16. MEC Erasmus MC MEC-2020-0778. CCMO NL74623.078.21.
| Original language | English |
|---|---|
| Article number | 18 |
| Journal | Trials |
| Volume | 23 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 6 Jan 2022 |
Bibliographical note
Funding Information:The design and implementation of this study were conducted without the support of a specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Research and writing of this manuscript were indirectly supported by ONCODE (Dutch Cancer Society), but ONCODE had no part in formulating the hypothesis, construction of the study design, or conduction of the trial. JHJH was additionally supported by the European Research Council Advanced Grant Dam2Age, NIH grant (PO1 AG017242), and the Deutsche Forschungsgemeinschaft - Project-ID 73111208 - SFB 829 and JHJH and WPV by BBoL (NWO-ENW), ZonMW Memorabel (733050810), and EJP-RD TC-NER RD20-113.
Funding Information:
The authors would like to thank F. de Lange and M. Trzpis-Bremer for their contributions to the study protocol and study documents and their expertise regarding the medical ethical submittance process. We additionally would like to thank R.C.A van Linschoten for his epidemiological expertise and statistical consultation. Research and writing of this manuscript were indirectly supported by ONCODE (Dutch Cancer Society). Oncode Institute provided support in the preclinical research, but had no role in the design, preparation, or implementation of this trial. Trial sponsor: Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands & Oncode Institute, Utrecht, the Netherlands
Publisher Copyright:
© 2022, The Author(s).