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Impact of IDPN on Nutrition Markers in Patients Receiving ICHD

NCT05439174 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2022-09-29

No results posted yet for this study

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

Interventions

OTHER

Intradialytic Parenteral Nutrition

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.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Patient Care America

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2023-03-30
Completion
2023-03-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05439174 on ClinicalTrials.gov