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Impact of IDPN on Nutrition Markers in Patients Receiving ICHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05439174
Recruitment Status : Active, not recruiting
First Posted : June 30, 2022
Last Update Posted : September 29, 2022
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Patient Care America

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.

Condition or disease Intervention/treatment
End-stage Renal Disease Malnutrition; Protein Other: Intradialytic Parenteral Nutrition

Detailed Description:
Intradialytic parenteral nutrition (IDPN) has been identified as a means of improving nutrition status in malnourished hemodialysis patients who cannot meet calorie and protein needs with oral intake alone. The retrospective chart review spanning 3 years will be conducted on in-center hemodialysis patients receiving IDPN concurrent with their dialysis treatment. This study will evaluate the impact of intradialytic parenteral nutrition (IDPN) compounded with Clinisol, Prosol, Plenamine, Intralipid and/or Clinolipid on albumin levels in patients with end-stage renal disease (ESRD) undergoing in-center hemodialysis and determine if addition of Clinolipid changes response to IDPN therapy compared to IDPN without lipids or IDPN with Intralipid. The primary endpoint is change in albumin levels from baseline (average albumin of up to 3 months prior to initiation of IDPN therapy) to 6 months after IDPN therapy initiation for the full analysis set. Secondary endpoints will be analyzed and include: distinguishing factors between those that respond to IDPN therapy (0.2g/dL or more increase in albumin levels) and those that do not; assessing time to IDPN response (increase of 0.2g/dL in albumin levels); determining factors that predict IDPN response; and comparing amount of change in albumin levels, percent of patients responding to IDPN therapy, and amount of time to IDPN response between those that receive lipids with IDPN therapy and those that do not receive lipids.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Intradialytic Parenteral Nutrition on Nutrition Markers in Patients Receiving In-Center Hemodialysis
Actual Study Start Date : July 15, 2022
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : March 30, 2023



Intervention Details:
  • 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.

    Other Name: NutriRite


Primary Outcome Measures :
  1. Time from baseline to clinically significant improvement in albumin [ Time Frame: 6 months ]
    Albumin levels of study population will rise significantly (0.2g/dL) after 6 months of intradialytic parenteral nutrition (IDPN) therapy


Secondary Outcome Measures :
  1. Difference between use of IDPN without lipids, with Clinolipid, and with Intralipid [ Time Frame: 6 months ]
    Response time to therapy over an observation period of 6 months will be improved in patients receiving IDPN compounded with Clinolipid compared to patients receiving IDPN with Intralipid or no lipids.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • - 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05439174


Locations
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United States, Florida
Patient Care America
Pompano Beach, Florida, United States, 33064
Sponsors and Collaborators
Patient Care America
Baxter Healthcare Corporation
Publications of Results:
Other Publications:
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Responsible Party: Patient Care America
ClinicalTrials.gov Identifier: NCT05439174    
Other Study ID Numbers: IDPN and ICHD Study Protocol
First Posted: June 30, 2022    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Malnutrition
Kwashiorkor
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes
Nutrition Disorders
Severe Acute Malnutrition