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Dialysis Model for Outcome and Nutrition Decision (DIAMOND)

Primary Purpose

Protein-Calorie Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ONS
Sponsored by
An Hsin QingShui Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Protein-Calorie Malnutrition focused on measuring Prediction Model, Malnutrition, Hemodialysis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • An Hsin Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

1-year mortality
1-year mortality evaluated by cox model and logistic regression

Secondary Outcome Measures

Serum Albumin concentration change
comparing the serum albumin concentration in intervention and control groups during study.

Full Information

First Posted
August 18, 2018
Last Updated
August 8, 2022
Sponsor
An Hsin QingShui Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03642678
Brief Title
Dialysis Model for Outcome and Nutrition Decision
Acronym
DIAMOND
Official Title
Intervention Study for Validation of Application of a Prediction Model in Maintenance Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
April 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
An Hsin QingShui Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein-Calorie Malnutrition
Keywords
Prediction Model, Malnutrition, Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
422 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
ONS
Other Intervention Name(s)
Clinical Infection Screening, Clinical procedure for malnutrition prevention
Intervention Description
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.
Primary Outcome Measure Information:
Title
1-year mortality
Description
1-year mortality evaluated by cox model and logistic regression
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Serum Albumin concentration change
Description
comparing the serum albumin concentration in intervention and control groups during study.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huan Sheng Chen, MD
Organizational Affiliation
An Hsin QingShui Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
An Hsin Clinic
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Dialysis Model for Outcome and Nutrition Decision

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