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Dialysis Model for Outcome and Nutrition Decision

NCT03642678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2022-08-09

No results posted yet for this study

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.

Conditions

  • Protein-Calorie Malnutrition

Interventions

DIETARY_SUPPLEMENT

ONS

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.

Sponsors & Collaborators

  • An Hsin QingShui Clinic

    lead OTHER

Principal Investigators

  • Huan Sheng Chen, MD · An Hsin QingShui Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-05-31
Completion
2022-04-26

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03642678 on ClinicalTrials.gov