Improvement of nutritional state by intradialytical parenteral nutrition in children treated with haemodialysis

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2010
INTERVENTION: Malnourished children undergoing haemodialysis treatment (aged 6‐17 years) will be included in the study. None will be receiving growth hormone. Each patient will receive a three month course of either Treatment A or Treatment B. For ethical reasons there is no washout period and patients will be switched to another three months of either Treatment A or B in order to complete the other arm of the crossover design. 1. Treatment A: Dietary supplementation providing a third daily calorie intake three times per week. 2. Treatment B. A three months course of intradialytical parenteral nutrition in every haemodialysis session (three times per week). The IDPN will provide a third of the required daily calorie intake, amino acids and lipids, will be adjusted by age and sex. CONDITION: Malnutrition/Haemodialysis pediatric patients ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: Improvement in ABN score (anthropometry‐bioimpedance analysis‐nutrition) at 3 and 6 months SECONDARY OUTCOME: 1. improvement in inflammation biomarkers (IL‐6, TNF alpha); 1. Peripheral blood gene expression of IL6, TNF alpha, IFN gamma, 18s‐rRNA at baseline, 3 and 6 months; 2. Adverse events to nutritional intervention INCLUSION CRITERIA: 1. Patients aged 6‐17 years 2. Anthropometry‐BIA nutrition (ABN) Score <10.33 3. Functional haemodialysis vascular access 4. Expected time in haemodialysis at least 6 months 5. No evidence of active infection 6. Informed consent/assent properly signed
Epistemonikos ID: ac6000d00f2910b04d9be0ef3b67bf8ab0f65aff
First added on: Aug 22, 2024