Chronic Kidney DiseasesDiaPaNICNCT05568914
Intra Dialytic Parenteral Nutrition and Nutritional Gap Nutritional Gap Identified by Indirect Calorimetry
A study testing Indirect Calorimetry, Bio-electrical Impedance Analysis (BIA) and Nutritional assessments in people with Chronic Kidney Diseases and Protein Energy Wasting, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Protein Energy Wasting
- What is being tested?
- Indirect Calorimetry, Bio-electrical Impedance Analysis (BIA) and Nutritional assessments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Oct 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Pregnancy
- Contra-indications for the use of indirect calorimetry as stated by the AARC (oxygen therapy for COPD,...)
- Metabolic diseases
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
Elisabeth De Waele, MD. PhD., +3224763344, elisabeth.dewaele@uzbrussel.be
About this study
Official title: Intra Dialytic Parenteral Nutrition During Intermittent Hemodialysis Can Close the Nutritional Gap Identified by Indirect Calorimetry: a Pilot and Feasibility Study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Protein Energy Wasting
- Being tested
- Indirect Calorimetry, Bio-electrical Impedance Analysis (BIA), Nutritional assessments
- Keywords
- Indirect Calorimetry, Parenteral Nutrition, Hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect CalorimetryDevice
Also called Q-NRG Metabolic Monitor, COSMED
Indirect Calorimetry (Q-NRG Metabolic Monitor, COSMED) is performed to determine the Resting Energy Expenditure before hemodialysis.
Bio-electrical Impedance Analysis (BIA)Device
Also called BIA101/BIVA, Akern
Bio-electrical Impedance Analysis (BIA101/BIVA, Akern) is used to analyse the body composition (Fat Mass, Fat Free Mass, Phase Angle).
Nutritional assessmentsOther
Also called Dietary anamnesis, Nutritional diary
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Indirect Calorimetry; Device: Bio-electrical Impedance Analysis (BIA); Other: Nutritional assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: Pre-dialysis
Secondary outcomes (11)
Protein adequacy
protein intake (from nutritional assessments)/protein need (%)
Measured: Pre-dialysis
Fat Mass (FM)
measured by Bio-electrical Impedance Analysis (BIA) (kg and %);
Measured: 20-30 minutes after dialysis
Fat Free Mass (FFM)
measured by Bio-electrical Impedance Analysis (BIA) (kg and %);
Measured: 20-30 minutes after dialysis
Phase angle
measured by Bio-electrical Impedance Analysis (BIA) (kg and %);
Measured: 20-30 minutes after dialysis
Body weight
Body weight (kg)
Measured: 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)
Measured: through study completion or one year, whichever is sooner
Mean caloric intake
(kcal/day) from nutritional assessments (3-day nutritional diary and nutritional anamnesis
Measured: pre-dialysis
Caloric need
(kcal/day): Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC)
Measured: pre-dialysis
Mean protein intake
g/day): from nutritional assessments (3-day nutritional diary and nutritional anamnesis
Measured: pre-dialysis
Barriers for patients for use of IDPN
"would you agree to IDPN if your health condition required it? Please elaborate"
Measured: 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."
Measured: throughout the duration of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start4 Oct 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Elisabeth De Waele, MD, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568914
- Sponsor's protocol ID
- 2022-EDW-DiaPaNIC
- Acronym
- DiaPaNIC
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Dialytic Parenteral Nutrition During Intermittent Hemodialysis Can Close the Nutritional Gap Identified by Indirect Calorimetry: a Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT05568914
- Acronym / sponsor ID
- DiaPaNIC / 2022-EDW-DiaPaNIC
- Conditions
- Chronic Kidney Diseases, Protein Energy Wasting
- Keywords
- Indirect Calorimetry, Parenteral Nutrition, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessments | Experimental | Device: Indirect Calorimetry, Device: Bio-electrical Impedance Analysis (BIA), Other: Nutritional assessmentsIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Pregnancy
- Contra-indications for the use of indirect calorimetry as stated by the AARC (oxygen therapy for COPD,...)
- Metabolic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect CalorimetryAlso: Q-NRG Metabolic Monitor, COSMEDIndirect Calorimetry (Q-NRG Metabolic Monitor, COSMED) is performed to determine the Resting Energy Expenditure before hemodialysis. | Device | Assessments |
| Bio-electrical Impedance Analysis (BIA)Also: BIA101/BIVA, AkernBio-electrical Impedance Analysis (BIA101/BIVA, Akern) is used to analyse the body composition (Fat Mass, Fat Free Mass, Phase Angle). | Device | Assessments |
| Nutritional assessmentsAlso: Dietary anamnesis, Nutritional diaryThe Nutritional assessments consist of a dietary anamnesis and a 3-day nutritional diary to determine the nutritional (caloric and protein) intake of the participants. | Other | Assessments |
Primary outcome
Caloric adequacy
Time frame: Pre-dialysis
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 (%)
11 secondary outcomes
Protein adequacy
Time frame: Pre-dialysis
Fat Mass (FM)
Time frame: 20-30 minutes after dialysis
Fat Free Mass (FFM)
Time frame: 20-30 minutes after dialysis
Phase angle
Time frame: 20-30 minutes after dialysis
Body weight
Time frame: before and after hemodialysis
Compatibility between the caloric gap and PN ready to use formulae on the market
Time frame: through study completion or one year, whichever is sooner
Mean caloric intake
Time frame: pre-dialysis
Caloric need
Time frame: pre-dialysis
Mean protein intake
Time frame: pre-dialysis
Barriers for patients for use of IDPN
Time frame: pre-dialysis
Barriers for dialysis nurses and nephrologists for use of IDPN
Time frame: throughout the duration of the trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth De Waele, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect Calorimetry, Bio-electrical Impedance Analysis (BIA) and Nutritional assessments in people with Chronic Kidney Diseases and Protein Energy Wasting, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth De Waele, MD, PhD (+3224763354, elisabeth.dewaele@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caloric adequacy (time frame: Pre-dialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.