Dialysis Model for Outcome and Nutrition Decision

NCT03642678 | Completed

• 1 other identifier: DIAMOND
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prediction Model; Malnutrition; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 1-year mortality

  1-year mortality evaluated by cox model and logistic regression

  up to 12 months

Secondary Outcomes (1)

• Serum Albumin concentration change

  up to 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

ONS DIETARY_SUPPLEMENT

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

Intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• An Hsin QingShui Clinic: lead

Study Sites (1)

An Hsin Clinic

Taichung, Taiwan

Location

MeSH Terms

Conditions

Protein-Energy Malnutrition; Malnutrition

Condition Hierarchy (Ancestors)

Protein Deficiency; Deficiency Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Huan Sheng Chen, MD

  An Hsin QingShui Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: August 22, 2018
• Study Start: June 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: April 26, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)