Intra Dialytic Parenteral Nutrition and Nutritional Gap Nutritional Gap Identified by Indirect Calorimetry

NCT05568914 | Unknown

• 1 other identifier: 2022-EDW-DiaPaNIC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Renal failure is a relevant condition as the incidence of patients treated with intermittent dialysis continues to grow each year. One of the strongest predictors of mortality in these patients is Protein-Energy Wasting (PEW). Optimal nutritional support, combined with physical exercise may be able to improve the physical condition objectified as muscle wasting and weakness. Correct nutritional support must aim to supplement the correct combination of protein and caloric needs. Although no other way exist than predicting formula to assess protein need, predicting formula don't seem to capture the individual caloric need of the patients. The gold standard to assess caloric need by measuring Resting Energy Expenditure (REE) is indirect calorimetry. Even when caloric and protein targets are defined, intake remains a challenge because of intake restriction in dietary patterns. This is why intradialytic parenteral nutrition (IDPN) can play an crucial role for closing the nutritional gap. Whether IDPN guided by indirect calorimetric measurements of metabolism can close the gap when oral intake fails, remains an unanswered question.

Conditions

Chronic Kidney Diseases; Protein Energy Wasting

Keywords

Indirect Calorimetry; Parenteral Nutrition; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Caloric adequacy

  caloric intake (kcal/day) and caloric need (kcal/day) (see secondary outcomes) will be combined to report caloric adequacy according to this equation: \[sum of percentage of caloric intake/caloric need\]/total of evaluable nutrition days (%)

  Pre-dialysis

Secondary Outcomes (11)

• Protein adequacy

  Pre-dialysis

• Fat Mass (FM)

  20-30 minutes after dialysis

• Fat Free Mass (FFM)

  20-30 minutes after dialysis

• Phase angle

  20-30 minutes after dialysis

• Body weight

  before and after hemodialysis

Other Outcomes (6)

• Descriptive outcomes

  pre-dialysis

• Dialysis type

  During dialysis

• Delta REE between predicting formula and indirect calorimetry

  Pre-dialysis

Study Arms (1)

Assessments

EXPERIMENTAL

In this single-arm trial, each participant undergoes the following measurements/assessments: Physical: Body weight (before and after dialysis), length Biophysical: NRS2002, GLIM, Bio-electrical Impedance Analysis Metabolic: Indirect Calorimetry Nutritional: dietary anamnesis, 3-days nutritional diary

Device: Indirect Calorimetry; Device: Bio-electrical Impedance Analysis (BIA); Other: Nutritional assessments

Interventions

Indirect Calorimetry DEVICE

Indirect Calorimetry (Q-NRG Metabolic Monitor, COSMED) is performed to determine the Resting Energy Expenditure before hemodialysis.

Also known as: Q-NRG Metabolic Monitor, COSMED

Assessments

Bio-electrical Impedance Analysis (BIA) DEVICE

Bio-electrical Impedance Analysis (BIA101/BIVA, Akern) is used to analyse the body composition (Fat Mass, Fat Free Mass, Phase Angle).

Also known as: BIA101/BIVA, Akern

Assessments

Nutritional assessments OTHER

The Nutritional assessments consist of a dietary anamnesis and a 3-day nutritional diary to determine the nutritional (caloric and protein) intake of the participants.

Also known as: Dietary anamnesis, Nutritional diary

Assessments

Eligibility Criteria

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

You may qualify if:

• Patient on intermittent hemodialysis
• Protein-Energy Wasting defined as 5% within 3 months or 10% within 6 months (not due to water loss, established at the discretion of the treating physician)

You may not qualify if:

• Pregnancy
• Contra-indications for the use of indirect calorimetry as stated by the AARC (oxygen therapy for COPD,...)
• Metabolic diseases

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphagia

Interventions

Calorimetry, Indirect; Nutrition Assessment

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calorimetry; Chemistry Techniques, Analytical; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Elisabeth De Waele, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth De Waele, MD, PhD

CONTACT

+3224763354; elisabeth.dewaele@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: October 6, 2022
• Study Start: October 4, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)