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Fasting before live kidney donation, effect on donor wellbeing and postoperative recovery

Fasting before live kidney donation, effect on donor wellbeing and postoperative recovery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22140
Enrollment
180
Registered
2021-02-24
Start date
2021-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Live kidney donation, postoperative recovery, ischemia-reperfusion injury

Interventions

Subjects in the intervention group will start a preoperative fasting regime from 60 hours before surgery. Fasting is defined as very few to no caloric intake. Subjects are free to drink unlimited wate

Sponsors

Investigator Initiated
Lead Sponsor

Eligibility

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 - Able to provide written consent - Adequate understanding of the Dutch language

Exclusion criteria

Exclusion criteria: A potential subject (Donor) 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 living kidney donors - HLA- or bloodtype-incompatible living kidney donation A potential subject (Recipient) who meets any of the following criteria will be excluded from participation in this study: - the use of double anticoagulants (f.i. Ascal (Carbasalate Calcium) and Clopidogrel (Plavix)). - the need for therapeutic anticoagulation with low-molecular weight heparine during admission for kidney transplantation, also known as “Bridging”.

Design outcomes

Primary

MeasureTime frame
Postoperative fatigue, scored by 36-Item Short Form Health Survey (RAND-36). The primary endpoint will be measured 4 weeks after surgery.

Secondary

MeasureTime frame
Our secondary endpoints comprise several aspects of the preoperative fasting diet, postoperative recovery and ischemia-reperfusion-injury: postoperative fatigue, admission time, adherence to the fasting diet, physical activity, renal function of the donor and recipient, upregulation of cytoprotective genes and anti-inflammatory markers, the use of uEV as a diagnostic approach and the immune-modulating effect of fasting.

Contacts

Public ContactChristiaan Oudmaijer

Erasmus MC, University Medical Center Rotterdam

c.oudmaijer@erasmusmc.nl010-7031810

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)