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

Intra Dialytic Parenteral Nutrition During Intermittent Hemodialysis Can Close the Nutritional Gap Identified by Indirect Calorimetry: a Pilot and Feasibility Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05568914
Acronym
DiaPaNIC
Enrollment
20
Registered
2022-10-06
Start date
2023-10-04
Completion date
2024-08-31
Last updated
2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Protein Energy Wasting

Keywords

Indirect Calorimetry, Parenteral Nutrition, Hemodialysis

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.

Detailed description

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.

Interventions

DEVICEIndirect Calorimetry

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

DEVICEBio-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).

OTHERNutritional 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

Baxter Healthcare Corporation
CollaboratorINDUSTRY
Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Caloric adequacyPre-dialysiscaloric 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 (%)

Secondary

MeasureTime frameDescription
Body weightbefore and after hemodialysisBody weight (kg)
Compatibility between the caloric gap and PN ready to use formulae on the marketthrough study completion or one year, whichever is soonerComparison 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)
Mean caloric intakepre-dialysis(kcal/day) from nutritional assessments (3-day nutritional diary and nutritional anamnesis
Caloric needpre-dialysis(kcal/day): Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC)
Mean protein intakepre-dialysisg/day): from nutritional assessments (3-day nutritional diary and nutritional anamnesis
Barriers for patients for use of IDPNpre-dialysiswould you agree to IDPN if your health condition required it? Please elaborate
Barriers for dialysis nurses and nephrologists for use of IDPNthroughout the duration of the trialAre logistical and practical barriers holding you back from prescribing or administering IDPV? Please elaborate.
Fat Free Mass (FFM)20-30 minutes after dialysismeasured by Bio-electrical Impedance Analysis (BIA) (kg and %);
Phase angle20-30 minutes after dialysismeasured by Bio-electrical Impedance Analysis (BIA) (kg and %);
Fat Mass (FM)20-30 minutes after dialysismeasured by Bio-electrical Impedance Analysis (BIA) (kg and %);
Protein adequacyPre-dialysisprotein intake (from nutritional assessments)/protein need (%)

Other

MeasureTime frameDescription
Dialysis typeDuring dialysis(from medical file)
Delta REE between predicting formula and indirect calorimetryPre-dialysisDifference in energy need as calculated using standard formula and measured using IC
Vascular access typeduring dialysis(from medical file)
Dialysis blood flow rateDuring dialysis(from medical file)
Hemodialysis treatment adequacy (kt/V)During dialysis(from medical file)
Descriptive outcomespre-dialysisage, sex, category of kidney disease, comorbidities, dialysis vintage (years)

Countries

Belgium

Contacts

Primary ContactElisabeth De Waele, MD, PhD
elisabeth.dewaele@uzbrussel.be+3224763354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026