Top

Published in:

Open Access 01-12-2022 | Fatigue | Study protocol

Fasting before living-kidney donation: effect on donor well-being and postoperative recovery: study protocol of a multicenter randomized controlled trial

Authors: C. A. J. Oudmaijer, R. C. Minnee, R. A. Pol, W. M. C. van den Boogaard, D. S. J. Komninos, J. van de Wetering, M. H. van Heugten, E. J. Hoorn, J. S. F. Sanders, J. H. J. Hoeijmakers, W. P. Vermeij, J. N. M. IJzermans

Published in: Trials | Issue 1/2022

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

Available only for authorised users

Małczak P, Pisarska M, Piotr M, Wysocki M, Budzyński A, Pędziwiatr M. Enhanced recovery after bariatric surgery: systematic review and meta-analysis. Obes Surg. 2017;27(1):226–35. https://doi.org/10.1007/s11695-016-2438-z.CrossRefPubMed

Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010;29(4):434–40. https://doi.org/10.1016/j.clnu.2010.01.004.CrossRefPubMed

Effectiviteit enhanced recovery after surgery. https://richtlijnendatabase.nl/. Accessed 10 July 2021.

Pędziwiatr M, Mavrikis J, Witowski J, Adamos A, Major P, Nowakowski M, et al. Current status of enhanced recovery after surgery (ERAS) protocol in gastrointestinal surgery. Med Oncol. 2018;35(6):95. https://doi.org/10.1007/s12032-018-1153-0.CrossRefPubMedPubMedCentral

Aarts MA, Okrainec A, Glicksman A, Pearsall E, Victor JC, McLeod RS. Adoption of enhanced recovery after surgery (ERAS) strategies for colorectal surgery at academic teaching hospitals and impact on total length of hospital stay. Surg Endosc. 2012;26(2):442–50. https://doi.org/10.1007/s00464-011-1897-5.CrossRefPubMed

Colman RJ, Anderson RM, Johnson SC, Kastman EK, Kosmatka KJ, Beasley TM, et al. Caloric restriction delays disease onset and mortality in rhesus monkeys. Science. 2009;325(5937):201–4. https://doi.org/10.1126/science.1173635.CrossRefPubMedPubMedCentral

Levolger S, van den Engel S, Ambagtsheer G, IJzermans JNM de Bruin RWF. Caloric restriction is associated with preservation of muscle strength in experimental cancer cachexia. Aging. 2018;10(12):4213-23. https://doi.org/10.18632/aging.101724.

Nakagawa S, Lagisz M, Hector KL, Spencer HG. Comparative and meta-analytic insights into life extension via dietary restriction. Aging Cell. 2012;11(3):401–9. https://doi.org/10.1111/j.1474-9726.2012.00798.x.CrossRefPubMed

Robertson LT, Mitchell JR. Benefits of short-term dietary restriction in mammals. Exp Gerontol. 2013;48(10):1043–8. https://doi.org/10.1016/j.exger.2013.01.009.CrossRefPubMedPubMedCentral

10.

van den Boogaard WM, van den Heuvel-Eibrink MM, Hoeijmakers JH, Vermeij WP. Nutritional preconditioning in cancer treatment in relation to DNA damage and aging. Annl Rev Cancer Biol. 2021;5(1):161–79. https://doi.org/10.1146/annurev-cancerbio-060820-090737.

11.

Schumacher B, van der Pluijm I, Moorhouse MJ, Kosteas T, Robinson AR, Suh Y, et al. Delayed and accelerated aging share common longevity assurance mechanisms. PLoS Genet. 2008;4(8):e1000161. https://doi.org/10.1371/journal.pgen.1000161.CrossRefPubMedPubMedCentral

12.

Schumacher B, Pothof J, Vijg J, Hoeijmakers JHJ. The central role of DNA damage in the ageing process. Nature. 2021;592(7856):695–703. https://doi.org/10.1038/s41586-021-03307-7.CrossRefPubMed

13.

Niedernhofer LJ, Garinis GA, Raams A, Lalai AS, Robinson AR, Appeldoorn E, et al. A new progeroid syndrome reveals that genotoxic stress suppresses the somatotroph axis. Nature. 2006;444(7122):1038–43. https://doi.org/10.1038/nature05456.CrossRefPubMed

14.

Garinis GA, Uittenboogaard LM, Stachelscheid H, Fousteri M, van Ijcken W, Breit TM, et al. Persistent transcription-blocking DNA lesions trigger somatic growth attenuation associated with longevity. Nat Cell Biol. 2009;11(5):604–15. https://doi.org/10.1038/ncb1866.CrossRefPubMedPubMedCentral

15.

Dorling JL, Das SK, Racette SB, Apolzan JW, Zhang D, Pieper CF, et al. Changes in body weight, adherence, and appetite during 2 years of calorie restriction: the CALERIE 2 randomized clinical trial. Eur J Clin Nutr. 2020;74(8):1210–20. https://doi.org/10.1038/s41430-020-0593-8.CrossRefPubMedPubMedCentral

16.

Redman LM, Heilbronn LK, Martin CK, Alfonso A, Smith SR, Ravussin E, et al. Effect of calorie restriction with or without exercise on body composition and fat distribution. J Clin Endocrinol Metab. 2007;92(3):865–72. https://doi.org/10.1210/jc.2006-2184.CrossRefPubMed

17.

Rochon J, Bales CW, Ravussin E, Redman LM, Holloszy JO, Racette SB, et al. Design and conduct of the CALERIE study: comprehensive assessment of the long-term effects of reducing intake of energy. J Gerontol A Biol Sci Med Sci. 2011;66(1):97–108. https://doi.org/10.1093/gerona/glq168.CrossRefPubMed

18.

Jongbloed F, De Bruin RW, Pennings JL, Payán-Gómez C, Van Den Engel S, Van Oostrom CT, et al. Preoperative fasting protects against renal ischemia-reperfusion injury in aged and overweight mice. PLoS One. 2014;9(6):e100853.

19.

Chen G, Bridenbaugh EA, Akintola AD, Catania JM, Vaidya VS, Bonventre JV, et al. Increased susceptibility of aging kidney to ischemic injury: identification of candidate genes changed during aging, but corrected by caloric restriction. Am J Physiol Renal Physiol. 2007;293(4):F1272–81. https://doi.org/10.1152/ajprenal.00138.2007.CrossRefPubMed

20.

Jongbloed F, Saat TC, Verweij M, Payán-Gómez C, Hoeijmakers JH, van den Engel S, et al. A signature of renal stress resistance induced by short-term dietary restriction, fasting, and protein restriction. Sci Rep. 2017;7:1.

21.

Vermeij WP, Dollé M, Reiling E, Jaarsma D, Payan-Gomez C, Bombardieri CR, et al. Restricted diet delays accelerated ageing and genomic stress in DNA-repair-deficient mice. Nature. 2016;537(7620):427–31. https://doi.org/10.1038/nature19329.CrossRefPubMedPubMedCentral

22.

Shushimita S, van der Pol P, De Bruin RWF, JNM I, Van Kooten C, Dor FJ. Mannan-binding lectin is involved in the protection against renal ischemia/reperfusion injury by dietary restriction. PLoS One. 2015;10(9):e0137795.

23.

van Ginhoven TM, de Bruin RW, Timmermans M, Mitchell JR, Hoeijmakers JH, Ijzermans JN. Pre-operative dietary restriction is feasible in live-kidney donors. Clin Transplant. 2011;25(3):486–94. https://doi.org/10.1111/j.1399-0012.2010.01313.x.CrossRefPubMed

24.

Jongbloed F, De Bruin RWF, Klaassen RA, Beekhof P, Van Steeg H, Dor FJMF, et al. Short-term preoperative calorie and protein restriction is feasible in healthy kidney donors and morbidly obese patients scheduled for surgery. Nutrients. 2016;8(5)306.

25.

Jongbloed F, de Bruin RWF, Steeg HV, Beekhof P, Wackers P, Hesselink DA, et al. Protein and calorie restriction may improve outcomes in living kidney donors and kidney transplant recipients. Aging (Albany NY). 2020;12:12441.CrossRef

26.

de Groot S, Lugtenberg RT, Cohen D, Welters MJP, Ehsan I, Vreeswijk MPG, et al. Fasting mimicking diet as an adjunct to neoadjuvant chemotherapy for breast cancer in the multicentre randomized phase 2 DIRECT trial. Nat Commun. 2020;11(1):3083. https://doi.org/10.1038/s41467-020-16138-3.CrossRefPubMedPubMedCentral

27.

Mitchell JR, Verweij M, Brand K, Van De Ven M, Goemaere N, Van Den Engel S, et al. Short-term dietary restriction and fasting precondition against ischemia reperfusion injury in mice. Aging Cell. 2010;9(1):40–53. https://doi.org/10.1111/j.1474-9726.2009.00532.x.

28.

van Ginhoven TM, Mitchell JR, Verweij M, Hoeijmakers JH, Ijzermans JN, de Bruin RW. The use of preoperative nutritional interventions to protect against hepatic ischemia-reperfusion injury. Liver Transpl. 2009;15(10):1183–91. https://doi.org/10.1002/lt.21871.CrossRefPubMed

29.

Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet. 2004;364(9447):1814–27. https://doi.org/10.1016/S0140-6736(04)17406-0.CrossRefPubMed

30.

Fletcher JT, Nankivell BJ, Alexander SI. Chronic allograft nephropathy. Pediatr Nephrol. 2009;24(8):1465–71. https://doi.org/10.1007/s00467-008-0869-z.CrossRefPubMedPubMedCentral

31.

Devarajan P, Mishra J, Supavekin S, Patterson LT, Steven PS. Gene expression in early ischemic renal injury: clues towards pathogenesis, biomarker discovery, and novel therapeutics. Mol Genet Metab. 2003;80(4):365–76. https://doi.org/10.1016/j.ymgme.2003.09.012.CrossRefPubMed

32.

Jang HR, Ko GJ, Wasowska BA, Rabb H. The interaction between ischemia-reperfusion and immune responses in the kidney. J Mol Med (Berl). 2009;87(9):859–64. https://doi.org/10.1007/s00109-009-0491-y.CrossRef

33.

Thurman JM. Triggers of inflammation after renal ischemia/reperfusion. Clin Immunol. 2007;123(1):7–13. https://doi.org/10.1016/j.clim.2006.09.008.CrossRefPubMed

34.

Saat TC, van den Akker EK, JN IJ, Dor FJ, de Bruin RW. Improving the outcome of kidney transplantation by ameliorating renal ischemia reperfusion injury: lost in translation? J Transl Med. 2016;14:1.

35.

Racette SB, Weiss EP, Villareal DT, Arif H, Steger-May K, Schechtman KB, et al. One year of caloric restriction in humans: feasibility and effects on body composition and abdominal adipose tissue. J Gerontol A Biol Sci Med Sci. 2006;61(9):943–50. https://doi.org/10.1093/gerona/61.9.943.CrossRefPubMed

36.

Klop KWJ, Timman R, Busschbach JJ, Dols LFC, Dooper IM, Weimar W, et al. Multivariate analysis of health-related quality of life in donors after live kidney donation. Transplant Proc. 2018;50(1):42–7. https://doi.org/10.1016/j.transproceed.2017.10.019.CrossRefPubMed

37.

Wirken L, van Middendorp H, Hooghof CW, Rovers MM, Hoitsma AJ, Hilbrands LB, et al. The course and predictors of health-related quality of life in living kidney donors: a systematic review and meta-analysis. Am J Transplant. 2015;15(12):3041–54. https://doi.org/10.1111/ajt.13453.CrossRefPubMed

38.

Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Bmj. 2013;346(jan08 15):e7586. https://doi.org/10.1136/bmj.e7586.CrossRefPubMedPubMedCentral

39.

Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993;2(3):217-27. https://doi.org/10.1002/hec.4730020305.

40.

Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R, et al. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998;51(11):1055–68. https://doi.org/10.1016/S0895-4356(98)00097-3.CrossRefPubMed

41.

Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000;84(1):11–5. https://doi.org/10.1093/oxfordjournals.bja.a013366.CrossRefPubMed

42.

Gornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, et al. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013;111(2):161–9. https://doi.org/10.1093/bja/aet014.CrossRefPubMed

43.

Rowlands AV, Sherar LB, Fairclough SJ, Yates T, Edwardson CL, Harrington DM, et al. A data-driven, meaningful, easy to interpret, standardised accelerometer outcome variable for global surveillance. J Sci Med Sport. 2019;22(10):1132–8. https://doi.org/10.1016/j.jsams.2019.06.016.CrossRefPubMed

44.

Arvidsson D, Fridolfsson J, Börjesson M. Measurement of physical activity in clinical practice using accelerometers. J Intern Med. 2019;286(2):137–53. https://doi.org/10.1111/joim.12908.CrossRefPubMed

45.

Lin WY, Verma VK, Lee MY, Lai CS. Activity monitoring with a wrist-worn, accelerometer-based device. Micromachines (Basel). 2018;9(9):450.CrossRef

46.

Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001;33(5):350–7. https://doi.org/10.3109/07853890109002089.CrossRefPubMed

47.

Roufosse C, Simmonds N, Clahsen-van Groningen M, Haas M, Henriksen KJ, Horsfield C, et al. A 2018 reference guide to the Banff classification of renal allograft pathology. Transplantation. 2018;102(11):1795–814. https://doi.org/10.1097/TP.0000000000002366.CrossRefPubMedPubMedCentral

48.

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205–13. https://doi.org/10.1097/01.sla.0000133083.54934.ae.CrossRefPubMedPubMedCentral

Title: Fasting before living-kidney donation: effect on donor well-being and postoperative recovery: study protocol of a multicenter randomized controlled trial
Authors: C. A. J. Oudmaijer
R. C. Minnee
R. A. Pol
W. M. C. van den Boogaard
D. S. J. Komninos
J. van de Wetering
M. H. van Heugten
E. J. Hoorn
J. S. F. Sanders
J. H. J. Hoeijmakers
W. P. Vermeij
J. N. M. IJzermans
Publication date: 01-12-2022
Publisher: BioMed Central
Keyword: Fatigue
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05950-x

Study protocol

A cluster-randomised, non-inferiority trial of the impact of a two-dose compared to three-dose schedule of pneumococcal conjugate vaccination in rural Gambia: the PVS trial

Study protocol

Effects of physical training on physical and functional fitness, physical activity level, endothelial function, hemodynamic variables, bone metabolism, and quality of life of post-bariatric patients: study protocol for a randomized controlled trial

Study protocol

Exploring the effects of a combined exercise programme on pain and fatigue outcomes in people with systemic sclerosis: study protocol for a large European multi-centre randomised controlled trial

Study protocol

Effectiveness of a Mindful Compassion Care Program in reducing burnout and psychological distress amongst frontline hospital nurses during the COVID-19 pandemic: a study protocol for a randomized controlled trial

Study protocol

An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)

Study protocol

TRial to Assess Implementation of New research in a primary care Setting (TRAINS): study protocol for a pragmatic cluster randomised controlled trial of an educational intervention to promote asthma prescription uptake in general practitioner practices

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Fasting before living-kidney donation: effect on donor well-being and postoperative recovery: study protocol of a multicenter randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

A cluster-randomised, non-inferiority trial of the impact of a two-dose compared to three-dose schedule of pneumococcal conjugate vaccination in rural Gambia: the PVS trial

Effects of physical training on physical and functional fitness, physical activity level, endothelial function, hemodynamic variables, bone metabolism, and quality of life of post-bariatric patients: study protocol for a randomized controlled trial

Exploring the effects of a combined exercise programme on pain and fatigue outcomes in people with systemic sclerosis: study protocol for a large European multi-centre randomised controlled trial

Effectiveness of a Mindful Compassion Care Program in reducing burnout and psychological distress amongst frontline hospital nurses during the COVID-19 pandemic: a study protocol for a randomized controlled trial

An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)

TRial to Assess Implementation of New research in a primary care Setting (TRAINS): study protocol for a pragmatic cluster randomised controlled trial of an educational intervention to promote asthma prescription uptake in general practitioner practices