An interventional study of ONS in Protein-Calorie Malnutrition, sponsored by An Hsin QingShui Clinic. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by An Hsin QingShui Clinic · Not applicable, Interventional, and Treatment
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.
1,588 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 422 is above the median of 90 across 1,135 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →An Hsin QingShui Clinic is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Participants identified as high-risk for malnutrition-related mortality by prediction model are cluster-randomized into study group. Interventions: In this group, participants will be given common clinical screening for clinical or sub-clinical infection and also oral nutrition supplement (ONS) if albumin is \< 3.8 g/dl. Parameters for outcome measurements are recorded monthly (such as biochemical data) or quarterly (such as Body Composition Monitor (BCM) or Malnutrition Inflammatory Score (MIS). Hospitalization or Mortality events will be recorded when happened.
Dietary Supplement: ONS
Participants identified as high-risk for malnutrition-related mortality by prediction model are cluster-randomized into control group. In this group, participants will not be given any intervention, but only outcome measurements are recorded monthly (such as biochemical data) or quarterly (such as Body Composition Monitor (BCM) or Malnutrition Inflammatory Score (MIS). Hospitalization or Mortality events will be recorded when happened.
High-risk patients identified by prediction model in study group are intervened by pre-defined intervention protocol, which include oral nutrition supply, infection prevention, bp control and improving of dialysis therapy options and so on.
Also known as: Clinical Infection Screening, Clinical procedure for malnutrition prevention
1-year mortality
1-year mortality evaluated by cox model and logistic regression
Time frame: up to 12 months
Serum Albumin concentration change
comparing the serum albumin concentration in intervention and control groups during study.
Time frame: up to 12 months
Plan to share: No
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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An Hsin QingShui Clinic