Fasting Intervention for children with Unilateral Renal Tumours to reduce Toxicity
- Conditions
- Acute kidney injury, renal tumours
- Registration Number
- NL-OMON27995
- Lead Sponsor
- Princess Máxima Center for Paediatric Oncology (Investigator-Initiated)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Patients diagnosed with and/or a strong clinical suspicion of a unilateral malignant renal tumour without metastatic disease (either WT, RT, CCS, RCC, CMN, etc.) at Princess Máxima Centre for Paediatric Oncology. Since biopsy and therefore histological diagnosis of the type of renal tumour is not mandatory preoperatively, there needs to be a strong clinical suspicion or diagnosis of a renal tumour, opting for surgical excision after preoperative chemotherapy (treatment planned according to SIOP-RTSG-UMBRELLA).
unilateral localized renal tumours, not metachronous, planned radical tumour-nephrectomy, adequate understanding of the Dutch language.
Bilateral renal involvement, anorexia / very low body weight (for subjects younger than 1 year: SD-score < -2 for weight by age, for subjects older than 1 year: SD-score < -2 for weight by height), underlying metabolic disease prohibiting a period of fasting, metastatic disease, unilateral local and metachronous disease, no curative treatment possible or opting for Nephron-Sparing Surgery (NSS).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of Acute Kidney Injury (AKI) on postoperative day 3 (48-72 hours after end of anaesthesia)
- Secondary Outcome Measures
Name Time Method Postoperative renal function, postoperative renal injury, side effects, adherence to fasting, change in fasting parameters, body weight, subject wellbeing, physical activity, neuromotor performance, duration of postoperative hospital stay, admission to ICU, expression of cytoprotective/anti-oxidant genes.