Evidence map›Paper›PMID 34991694›Full record

ArticleTrials2022

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

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 and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.4field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Observational
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 2 countries.

C A J OudmaijerErasmus 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.ORCID http://orcid.org/0000-0003-4852-6514
R C MinneeErasmus 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.
R A PolDepartment of Transplantation Surgery, University Medical Center Groningen, Groningen, the Netherlands.
W M C van den BoogaardPrincess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands.
D S J KomninosPrincess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands.
J van de WeteringDepartment of Internal Medicine, Division of Nephrology and Transplantation, Erasmus University Medical Center, Rotterdam, the Netherlands.
M H van HeugtenDepartment of Internal Medicine, Division of Nephrology and Transplantation, Erasmus University Medical Center, Rotterdam, the Netherlands.
E J HoornDepartment of Internal Medicine, Division of Nephrology and Transplantation, Erasmus University Medical Center, Rotterdam, the Netherlands.
J S F SandersDepartment of Internal Medicine, Division of Nephrology and Transplantation, University Medical Center Groningen, Groningen, the Netherlands.
J H J HoeijmakersPrincess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands.
W P VermeijPrincess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands.
J N M IJzermansErasmus 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.
Erasmus MC · NLOncode Institute · NLUniversity Medical Center Groningen · NLUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOne 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.

methodsWe 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 registrationNetherlands Trial Register NL9262 . EudraCT 2020-005445-16 . MEC Erasmus MC MEC-2020-0778. CCMO NL74623.078.21.

Indexed as

Kidney TransplantationQuality of LifeFastingHumansKidneyLiving DonorsMulticenter Studies as TopicRandomized Controlled Trials as TopicFastingIschemia-reperfusion injuryLiving-kidney donationPostoperative recovery

Identifiers

PMID34991694
PMCPMC8733810
OpenAlexW4205269641

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.