Dialysis Model for Outcome and Nutrition Decision
Dialysis Model for Outcome and Nutrition Decision
This study is the secondary phase of Taiwan Prediction Model Project Plan (TPMPP). The
 investigators try to design a prospective randomized control trial with nutrition
 intervention to validate 3 prediction models the investigators developed in the first phase.
 Proper validation of these models is mandatory before they can be applied and implemented
 into daily clinical practice. At present, around 20 centers with estimated around 550-650
 high-risk patients will be enrolled with 1:1 ratio in study and control groups. Following up
 of parameters about primary and secondary outcomes will be done in both groups. But a
 pre-designed intervention protocol, which is according to 3 elucidated screening methods,
 will be applied only to the study group. The total study period will be one year.
Chronic kidney disease (CKD) is a major public health concern. Progression of CKD leads to
 end-stage renal disease (ESRD), a total and permanent failure of kidney function requiring
 kidney transplant or maintenance hemodialysis. Among the numerous risk factors of mortality,
 severe malnutrition, now defined as protein energy wasting (PEW), which is manifested by low
 serum levels of albumin or pre-albumin, sarcopenia and weight loss, is one of the strongest
 predictors of mortality, morbidity and infection-related hospitalizations in hemodialysis
 (HD) patients. When PEW is present or the patient is at high risk, oral intradialytic or
 daily supplements, aiming at increasing energy and protein intake, while in selected cases
 intra-dialytic parenteral nutrition may be used for the clinician. Previous reports showed
 that providing patients with intradialytic food, liquid supplements, or parenteral nutrition
 has been shown to compensate for this loss. In patients with ESRD, it is important to prevent
 PEW through a regular nutritional status evaluation and nutritional counseling by a renal
 dietitian. Intradialytic administration of oral or parenteral supplementation of nutrients is
 safe and should be encouraged in selected patients. Although the problem of malnutrition
 became more and more serious due to the increasingly aging and Diabetes Mellitus (DM)
 proportion in HD population, there are still no universally accepted methods to early detect
 or predict this problem. Thus, the intention for early intervention to suitable patients
 faces difficulty. In Taiwan Prediction Model Project Plan (TPMPP), the investigators try to
 develop a model using common available clinical data with the utilization of current machine
 learning methods to early detect the patients with high risks for malnutrition and the
 investigators wish through the routine application of this model, the investigators can do
 nutrition intervention in much earlier stage and improve the patients' outcome. In the first
 stage of TPMPP, the investigators have developed some prediction models through an abundant
 retrospective database collected in Fresenius Database (NephroWeb) from 2011-2018. Before
 real implementation of these models in clinical practice, the investigators need to validate
 these models with prospective design with proper intervention, this is the main purpose of
 this study. The Body Composition Monitor with the principle of Bioimpedance Spectroscopy
 (BCMBIS, Fresenius Medical Care) is a simple and accurate tool for the assessment of body
 composition. Recently, the lean and fat mass indexes (LTI, FTI), derived from BCM, have
 become good predictors of mortality in HD individuals, which have been more sensitive to
 malnutrition, and altogether anthropometric indicators may result in an early detection of
 mortality risk in this population. Thus, the investigators also try to apply these parameters
 in this study as important nutrition outcomes for follow-up.
Inclusion Criteria:

 -  Maintenance Hemodialysis Patients (MHD) patients from multiple centers identified by
 the risk models as high-risk patients

 Exclusion Criteria:

 -  Acute patients

 -  Terminal Cancer Patients with life expectancy < 3 months

 -  Age < 20 year-old

 -  Active infection, including Tuberculosis and AIDS

 -  Patients received ONS 1 month before enrollment

 -  Pregnancy