Impact of IDPN on Nutrition Markers in Patients Receiving ICHD

End-stage Renal Disease Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic
• Kwashiorkor
• Malnutrition
• Malnutrition; Protein

• NCT number: NCT05439174
• Study type: Observational
• Source: Patient Care America
• Status: Active, not recruiting
• Start date: July 15, 2022
• Completion date: March 30, 2023