An interventional study of Indirect Calorimetry and Bio-electrical Impedance Analysis (BIA) in Chronic Kidney Diseases and Protein Energy Wasting, sponsored by Universitair Ziekenhuis Brussel. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Supportive care
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
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
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
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
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
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 (%)
Time frame: Pre-dialysis
Protein adequacy
protein intake (from nutritional assessments)/protein need (%)
Time frame: Pre-dialysis
Fat Mass (FM)
measured by Bio-electrical Impedance Analysis (BIA) (kg and %);
Time frame: 20-30 minutes after dialysis
Fat Free Mass (FFM)
measured by Bio-electrical Impedance Analysis (BIA) (kg and %);
Time frame: 20-30 minutes after dialysis
Phase angle
measured by Bio-electrical Impedance Analysis (BIA) (kg and %);
Time frame: 20-30 minutes after dialysis
Body weight
Body weight (kg)
Time frame: before and after hemodialysis
Compatibility between the caloric gap and PN ready to use formulae on the market
Comparison between individual caloric need of patients and ready to use PN formulae (PeriOlimel N4E (Baxter), Olimel N5E (Baxter), Olimel N7E (Baxter), Olimel N9/N9E (Baxter), Olimel N12/N12E (Baxter), SMOFKabiven Ex-tra Amino (Fresenius), SMOFKabiven peripheral (Fresenius), SMOFKabiven Peri Low Osmo (Fresenius), SMOFKabiven E/EF (Frese-nius), Omegomel Peri (Baxter), Nutriflex Omega Special (B Braun); based on caloric content per bag of PN on the market (Unit of measurement: portion of PN bag (%) needed to close the caloric gap)
Time frame: through study completion or one year, whichever is sooner
Mean caloric intake
(kcal/day) from nutritional assessments (3-day nutritional diary and nutritional anamnesis
Time frame: pre-dialysis
Caloric need
(kcal/day): Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC)
Time frame: pre-dialysis
Mean protein intake
g/day): from nutritional assessments (3-day nutritional diary and nutritional anamnesis
Time frame: pre-dialysis
Barriers for patients for use of IDPN
"would you agree to IDPN if your health condition required it? Please elaborate"
Time frame: pre-dialysis
Barriers for dialysis nurses and nephrologists for use of IDPN
"Are logistical and practical barriers holding you back from prescribing or administering IDPV? Please elaborate."
Time frame: throughout the duration of the trial
Descriptive outcomes
age, sex, category of kidney disease, comorbidities, dialysis vintage (years)
Time frame: pre-dialysis
Dialysis type
(from medical file)
Time frame: During dialysis
Delta REE between predicting formula and indirect calorimetry
Difference in energy need as calculated using standard formula and measured using IC
Time frame: Pre-dialysis
Vascular access type
(from medical file)
Time frame: during dialysis
Dialysis blood flow rate
(from medical file)
Time frame: During dialysis
Hemodialysis treatment adequacy (kt/V)
(from medical file)
Time frame: During dialysis
Plan to share: No
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