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

NCT ID: NCT05568914

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-04

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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Renal failure is a relevant condition as the incidence of patients treated with renal replacement therapy and specifically intermittent dialysis, continues to grow each year. In 2021 up to 4845 patients required intermittent dialysis in Flanders, Belgium. Weight loss and homeostatic disturbances of energy and protein balances are often present in Chronic Kidney disease (CKD) and end-stage renal disease (ESRD).The international society of renal nutrition and metabolism defines Protein-Energy Wasting (PEW) as the state of nutritional and metabolic disorders in patients with CKD and ESRD, characterized by simultaneous loss of systemic body protein and energy stores. PEW is one of the strongest predictors of mortality in CKD patients. Up tot 54% of adults undergoing chronic intermittent haemodialysis (IHD) suffer from PEW due to a combination of the disease and therapy. Adequate nutritional therapy can reverse the negative impact of PEW. Optimal nutritional support, next to 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 after assessing the needs and intake of different nutrients. 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. This technique measures the individual VCO2 and VO2 and after integrating it into the Weir equation it calculates REE. Even when caloric and protein target 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. In clinical practice, in 38% of dialysis patients, IDPN is used. The most common IDPN were triple phase bags. Whether IDPN guided by indirect calorimetric measurements of metabolism can close the gap when oral intake fails, remains an unanswered question.

Conditions

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Chronic Kidney Diseases Protein Energy Wasting

Keywords

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Indirect Calorimetry Parenteral Nutrition Hemodialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Assessments

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

Group Type EXPERIMENTAL

Indirect Calorimetry

Intervention Type DEVICE

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

Bio-electrical Impedance Analysis (BIA)

Intervention Type DEVICE

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

Nutritional assessments

Intervention Type 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.

Interventions

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Indirect Calorimetry

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

Intervention Type DEVICE

Bio-electrical Impedance Analysis (BIA)

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

Intervention Type DEVICE

Nutritional assessments

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.

Intervention Type OTHER

Other Intervention Names

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Q-NRG Metabolic Monitor, COSMED BIA101/BIVA, Akern Dietary anamnesis Nutritional diary

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth De Waele, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Elisabeth De Waele, MD, PhD

Role: CONTACT

Phone: +3224763354

Email: [email protected]

Facility Contacts

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Elisabeth De Waele, MD. PhD.

Role: primary

Other Identifiers

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2022-EDW-DiaPaNIC

Identifier Type: -

Identifier Source: org_study_id