Impact of IDPN on Nutrition Markers in Patients Receiving ICHD (NCT05439174) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time from baseline to clinically significant improvement in albumin