UnknownNot Applicable

Impact of IDPN on Nutrition Markers in Patients Receiving ICHD

United States1,200 participantsStarted 2022-07-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time from baseline to clinically significant improvement in albumin

Timeframe: 6 months

Trial details

NCT IDNCT05439174

SponsorPatient Care America

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-03-30