Impact of IDPN on Nutrition Markers in Patients Receiving ICHD

September 26, 2022 updated by: Patient Care America

Impact of Intradialytic Parenteral Nutrition on Nutrition Markers in Patients Receiving In-Center Hemodialysis

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Pompano Beach, Florida, United States, 33064
        • Patient Care America

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patient Care America

Collaborators

Baxter Healthcare Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Anticipated)

March 30, 2023

Study Completion (Anticipated)

March 30, 2023

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDPN and ICHD Study Protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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