Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03642678 |
| Other study ID # |
DIAMOND |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
April 26, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
An Hsin QingShui Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
