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

NCT05568914 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-12-06

No results posted yet for this study

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

Interventions

DEVICE

Indirect Calorimetry

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

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).

OTHER

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.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Elisabeth De Waele, MD, PhD · Universitair Ziekenhuis Brussel

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-04
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Belgium

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 NCT05568914 on ClinicalTrials.gov