PMID- 34991694
OWN - NLM
STAT- MEDLINE
DCOM- 20220110
LR  - 20240405
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 23
IP  - 1
DP  - 2022 Jan 6
TI  - Fasting before living-kidney donation: effect on donor well-being and 
      postoperative recovery: study protocol of a multicenter randomized controlled 
      trial.
PG  - 18
LID - 10.1186/s13063-021-05950-x [doi]
LID - 18
AB  - 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.
CI  - (c) 2022. The Author(s).
FAU - Oudmaijer, C A J
AU  - Oudmaijer CAJ
AUID- ORCID: 0000-0003-4852-6514
AD  - Erasmus MC Transplant Institute, Department of Surgery, Division of Hepatobiliary 
      and Transplantation Surgery, Erasmus University Medical Center, Dr. 
      Molewaterplein 40, RG-220, 3015, GD, Rotterdam, the Netherlands. 
      c.oudmaijer@erasmusmc.nl.
AD  - Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands. 
      c.oudmaijer@erasmusmc.nl.
AD  - Oncode Institute, Utrecht, The Netherlands. c.oudmaijer@erasmusmc.nl.
FAU - Minnee, R C
AU  - Minnee RC
AD  - Erasmus MC Transplant Institute, Department of Surgery, Division of Hepatobiliary 
      and Transplantation Surgery, Erasmus University Medical Center, Dr. 
      Molewaterplein 40, RG-220, 3015, GD, Rotterdam, the Netherlands.
FAU - Pol, R A
AU  - Pol RA
AD  - Department of Transplantation Surgery, University Medical Center Groningen, 
      Groningen, the Netherlands.
FAU - van den Boogaard, W M C
AU  - van den Boogaard WMC
AD  - Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.
AD  - Oncode Institute, Utrecht, The Netherlands.
FAU - Komninos, D S J
AU  - Komninos DSJ
AD  - Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.
AD  - Oncode Institute, Utrecht, The Netherlands.
FAU - van de Wetering, J
AU  - van de Wetering J
AD  - Department of Internal Medicine, Division of Nephrology and Transplantation, 
      Erasmus University Medical Center, Rotterdam, the Netherlands.
FAU - van Heugten, M H
AU  - van Heugten MH
AD  - Department of Internal Medicine, Division of Nephrology and Transplantation, 
      Erasmus University Medical Center, Rotterdam, the Netherlands.
FAU - Hoorn, E J
AU  - Hoorn EJ
AD  - Department of Internal Medicine, Division of Nephrology and Transplantation, 
      Erasmus University Medical Center, Rotterdam, the Netherlands.
FAU - Sanders, J S F
AU  - Sanders JSF
AD  - Department of Internal Medicine, Division of Nephrology and Transplantation, 
      University Medical Center Groningen, Groningen, the Netherlands.
FAU - Hoeijmakers, J H J
AU  - Hoeijmakers JHJ
AD  - Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.
AD  - Oncode Institute, Utrecht, The Netherlands.
AD  - Erasmus MC Cancer Institute, Department of Molecular Genetics, Erasmus University 
      Medical Center Rotterdam, Rotterdam, the Netherlands.
AD  - Institute for Genome Stability in Ageing and Disease, Medical Faculty, University 
      of Cologne, Cologne, Germany.
AD  - Cologne Excellence Cluster for Cellular Stress Responses in Aging-Associated 
      Diseases (CECAD), Centre for Molecular Medicine Cologne (CMMC), University of 
      Cologne, Cologne, Germany.
FAU - Vermeij, W P
AU  - Vermeij WP
AD  - Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.
AD  - Oncode Institute, Utrecht, The Netherlands.
FAU - IJzermans, J N M
AU  - IJzermans JNM
AD  - Erasmus MC Transplant Institute, Department of Surgery, Division of Hepatobiliary 
      and Transplantation Surgery, Erasmus University Medical Center, Dr. 
      Molewaterplein 40, RG-220, 3015, GD, Rotterdam, the Netherlands.
LA  - eng
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20220106
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - Fasting
MH  - Humans
MH  - Kidney/surgery
MH  - *Kidney Transplantation/adverse effects
MH  - Living Donors
MH  - Multicenter Studies as Topic
MH  - *Quality of Life
MH  - Randomized Controlled Trials as Topic
PMC - PMC8733810
OTO - NOTNLM
OT  - Fasting
OT  - Ischemia-reperfusion injury
OT  - Living-kidney donation
OT  - Postoperative recovery
COIS- The authors declare that they have no competing interests.
EDAT- 2022/01/08 06:00
MHDA- 2022/01/11 06:00
PMCR- 2022/01/06
CRDT- 2022/01/07 05:48
PHST- 2021/07/29 00:00 [received]
PHST- 2021/12/17 00:00 [accepted]
PHST- 2022/01/07 05:48 [entrez]
PHST- 2022/01/08 06:00 [pubmed]
PHST- 2022/01/11 06:00 [medline]
PHST- 2022/01/06 00:00 [pmc-release]
AID - 10.1186/s13063-021-05950-x [pii]
AID - 5950 [pii]
AID - 10.1186/s13063-021-05950-x [doi]
PST - epublish
SO  - Trials. 2022 Jan 6;23(1):18. doi: 10.1186/s13063-021-05950-x.