Impact of IDPN on Nutrition Markers in Patients Receiving ICHD

NCT05439174 | Unknown

• 1 other identifier: IDPN and ICHD Study Protocol
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the impact of intradialytic parenteral nutrition (IDPN) compounded with Clinisol, Prosol, and/or Clinolipid on albumin levels and weight in patients with end-stage renal disease (ESRD) undergoing in-center hemodialysis. Determine the average duration of time it takes for albumin levels to rise ≥0.2g/dL from the initiation of IDPN therapy as this has been associated with significant change in mortality and hospitalization risk. The investigators expect levels to rise significantly within 4-6 months, there may be a difference in outcome in patients receiving IDPN compounded with amino acids and dextrose only vs IDPN compounded with amino acids, lipid, and dextrose.

Conditions

End-stage Renal Disease; Malnutrition; Protein

Outcome Measures

Primary Outcomes (1)

• Time from baseline to clinically significant improvement in albumin

  Albumin levels of study population will rise significantly (0.2g/dL) after 6 months of intradialytic parenteral nutrition (IDPN) therapy

  6 months

Secondary Outcomes (1)

• Difference between use of IDPN without lipids, with Clinolipid, and with Intralipid

  6 months

Interventions

Intradialytic Parenteral Nutrition OTHER

Intradialytic parenteral nutrition (IDPN) is compounded using a combination of dextrose (D70%) and amino acids (Prosol 20%, Clinisol 15%, or Plenamine 15%) with the option of adding lipids (Intralipid 20% prior to 8/2020, Clinolipid starting 8/2020 and after). Each prescription is dosed based on patient height, weight, and other nutrition considerations including but not limited to presence of wounds, recent hospitalizations, electrolyte imbalance, etc. Adjustments to prescription are made on an as needed basis to increase or decrease goal infusion rate, adjust protein levels, and/or add or remove lipids.

Also known as: NutriRite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes all adult (18 years or older) patients with end-stage renal disease (ESRD) receiving IDPN therapy while undergoing in-center hemodialysis 3 days per week.

You may qualify if:

• Receiving in-center hemodialysis 3 days per week
• Having any diagnosis of ESRD
• ICD-10 code N18.6
• IDPN therapy initiated between May 1, 2018 and April 30, 2021 (evaluating through October 31, 2021)
• Baseline data available, average of up to 3 months of albumin levels available prior to start of therapy
• Age 18 years or older at IDPN therapy initiation
• Consented to have their medical records used for research

You may not qualify if:

• \- Dialysis prescription deviates from the standard 3 days per week
• IDPN or intraperitoneal nutrition (IPN) therapy was initiated outside the research window
• Under 18 years of age at IDPN initiation
• History of liver disease or gastric bypass
• Undergoing cancer treatment at any time during IDPN therapy
• Receiving enteral nutrition support or total parenteral nutrition

Sponsors & Collaborators

• Patient Care America: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Patient Care America

Pompano Beach, Florida, 33064, United States

Location

Related Publications (6)

• Shah A, Bross R, Shapiro BB, Morrison G, Kopple JD. Dietary energy requirements in relatively healthy maintenance hemodialysis patients estimated from long-term metabolic studies. Am J Clin Nutr. 2016 Mar;103(3):757-65. doi: 10.3945/ajcn.115.112995. Epub 2016 Feb 10.

  PMID: 26864370 BACKGROUND

• Carrero JJ, Thomas F, Nagy K, Arogundade F, Avesani CM, Chan M, Chmielewski M, Cordeiro AC, Espinosa-Cuevas A, Fiaccadori E, Guebre-Egziabher F, Hand RK, Hung AM, Ikizler TA, Johansson LR, Kalantar-Zadeh K, Karupaiah T, Lindholm B, Marckmann P, Mafra D, Parekh RS, Park J, Russo S, Saxena A, Sezer S, Teta D, Ter Wee PM, Verseput C, Wang AYM, Xu H, Lu Y, Molnar MZ, Kovesdy CP. Global Prevalence of Protein-Energy Wasting in Kidney Disease: A Meta-analysis of Contemporary Observational Studies From the International Society of Renal Nutrition and Metabolism. J Ren Nutr. 2018 Nov;28(6):380-392. doi: 10.1053/j.jrn.2018.08.006.

  PMID: 30348259 BACKGROUND

• Marsen TA, Beer J, Mann H; German IDPN-Trial group. Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial. Clin Nutr. 2017 Feb;36(1):107-117. doi: 10.1016/j.clnu.2015.11.016. Epub 2015 Dec 12.

  PMID: 26708726 RESULT

• Pupim LB, Flakoll PJ, Ikizler TA. Nutritional supplementation acutely increases albumin fractional synthetic rate in chronic hemodialysis patients. J Am Soc Nephrol. 2004 Jul;15(7):1920-6. doi: 10.1097/01.asn.0000128969.86268.c0.

  PMID: 15213282 RESULT

• Pupim LB, Flakoll PJ, Brouillette JR, Levenhagen DK, Hakim RM, Ikizler TA. Intradialytic parenteral nutrition improves protein and energy homeostasis in chronic hemodialysis patients. J Clin Invest. 2002 Aug;110(4):483-92. doi: 10.1172/JCI15449.

  PMID: 12189242 RESULT

• Ortiz-Ortiz L, Contreras MF, Bojalil LF. The assay of delayed hypersensitivity to ribosomal proteins from Nocardia. Sabouraudia. 1972 Jul;10(2):147-51. doi: 10.1080/00362177285190291. No abstract available.

  PMID: 4557877 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic; Kwashiorkor

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 30, 2022
• Study Start: July 15, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

US (1)