Impact of IDPN on Nutrition Markers in Patients Receiving ICHD
- Conditions
- Malnutrition; ProteinEnd-stage Renal Disease
- Registration Number
- NCT05439174
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- 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
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- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time from baseline to clinically significant improvement in albumin 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
Name Time Method Difference between use of IDPN without lipids, with Clinolipid, and with Intralipid 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.
Trial Locations
- Locations (1)
Patient Care America
🇺🇸Pompano Beach, Florida, United States