Intra Dialytic Parenteral Nutrition and Nutritional Gap Nutritional Gap Identified by Indirect Calorimetry (DiaPaNIC)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Protein Energy Wasting
• Intervention / Treatment: Device: Indirect Calorimetry; Device: Bio-electrical Impedance Analysis (BIA); Other: Nutritional assessments

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth De Waele, MD, PhD; Phone Number: +3224763354; Email: elisabeth.dewaele@uzbrussel.be

Study Locations

• Belgium
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel
      • Contact: Elisabeth De Waele, MD. PhD.; Phone Number: +3224763344; Email: elisabeth.dewaele@uzbrussel.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Assessments; 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; Indirect Calorimetry (Q-NRG Metabolic Monitor, COSMED) is performed to determine the Resting Energy Expenditure before hemodialysis.; Other Names: Q-NRG Metabolic Monitor, COSMED; 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 Names: BIA101/BIVA, Akern; 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.; Other Names: Dietary anamnesis; Nutritional diary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%)	Pre-dialysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein adequacy	protein intake (from nutritional assessments)/protein need (%)	Pre-dialysis
Fat Mass (FM)	measured by Bio-electrical Impedance Analysis (BIA) (kg and %);	20-30 minutes after dialysis
Fat Free Mass (FFM)	measured by Bio-electrical Impedance Analysis (BIA) (kg and %);	20-30 minutes after dialysis
Phase angle	measured by Bio-electrical Impedance Analysis (BIA) (kg and %);	20-30 minutes after dialysis
Body weight	Body weight (kg)	before and after hemodialysis
Mean caloric intake	(kcal/day) from nutritional assessments (3-day nutritional diary and nutritional anamnesis	pre-dialysis
Caloric need	(kcal/day): Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC)	pre-dialysis
Mean protein intake	g/day): from nutritional assessments (3-day nutritional diary and nutritional anamnesis	pre-dialysis
Barriers for patients for use of IDPN	"would you agree to IDPN if your health condition required it? Please elaborate"	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."	throughout the duration of the trial
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)	through study completion or one year, whichever is sooner

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive outcomes	age, sex, category of kidney disease, comorbidities, dialysis vintage (years)	pre-dialysis
Dialysis type	(from medical file)	During dialysis
Delta REE between predicting formula and indirect calorimetry	Difference in energy need as calculated using standard formula and measured using IC	Pre-dialysis
Vascular access type	(from medical file)	during dialysis
Dialysis blood flow rate	(from medical file)	During dialysis
Hemodialysis treatment adequacy (kt/V)	(from medical file)	During dialysis

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Elisabeth De Waele, MD, PhD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Hemodialysis; Parenteral Nutrition; Indirect Calorimetry
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2022-EDW-DiaPaNIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No