Clinical trial NCT05568914: Intra Dialytic Parenteral Nutrition and Nutritional Gap Nutritional Gap Identified by Indirect Calorimetry
Official title: Intra Dialytic Parenteral Nutrition During Intermittent Hemodialysis Can Close the Nutritional Gap Identified by Indirect Calorimetry: a Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Protein Energy Wasting
Keywords: Indirect Calorimetry
Parenteral Nutrition
Hemodialysis
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2022-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caloric adequacy
timeFrame: Pre-dialysis
Secondary outcomes:
measure: Protein adequacy
timeFrame: Pre-dialysis
measure: Fat Mass (FM)
timeFrame: 20-30 minutes after dialysis
measure: Fat Free Mass (FFM)
timeFrame: 20-30 minutes after dialysis
measure: Phase angle
timeFrame: 20-30 minutes after dialysis
measure: Body weight
timeFrame: before and after hemodialysis
measure: Compatibility between the caloric gap and PN ready to use formulae on the market
timeFrame: through study completion or one year, whichever is sooner
measure: Mean caloric intake
timeFrame: pre-dialysis
measure: Caloric need
timeFrame: pre-dialysis
measure: Mean protein intake
timeFrame: pre-dialysis
measure: Barriers for patients for use of IDPN
timeFrame: pre-dialysis
measure: Barriers for dialysis nurses and nephrologists for use of IDPN
timeFrame: throughout the duration of the trial
Other outcomes:
measure: Descriptive outcomes
timeFrame: pre-dialysis
measure: Dialysis type
timeFrame: During dialysis
measure: Delta REE between predicting formula and indirect calorimetry
timeFrame: Pre-dialysis
measure: Vascular access type
timeFrame: during dialysis
measure: Dialysis blood flow rate
timeFrame: During dialysis
measure: Hemodialysis treatment adequacy (kt/V)
timeFrame: During dialysis
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Elisabeth De Waele, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: