Status:
UNKNOWN
Impact of IDPN on Nutrition Markers in Patients Receiving ICHD
Lead Sponsor:
Patient Care America
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
End-stage Renal Disease
Malnutrition; Protein
Eligibility:
All Genders
18+ years
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) underg...
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 ...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
July 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2023
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT05439174
Start Date
July 15 2022
End Date
March 30 2023
Last Update
September 29 2022
Active Locations (1)
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1
Patient Care America
Pompano Beach, Florida, United States, 33064