Phosphate-Containing Replacement Fluid for Patients Undergoing CRRT

Summary

Brief Summary: Evaluating a New Phosphate-Containing Fluid for Blood Purification (CRRT) Why is this study being done? Patients in the Intensive Care Unit (ICU) often need a treatment called Continuous Renal Replacement Therapy (CRRT). This is a type of blood purification that acts like an artificial kidney to clear toxins and extra fluid from the body. A common problem during this treatment is that vital minerals, like phosphate, are washed out of the blood along with the toxins. Low phosphate can lead to muscle weakness and breathing problems. Currently, doctors must manually add phosphate to the treatment fluids, which can be inconsistent. This study aims to test a new, pre-mixed fluid that already contains phosphate to see if it works better and is safe. What are the main questions the study aims to answer? Does the new fluid help keep phosphate at a healthy level in the blood during the first 72 hours of treatment? How does the new fluid affect kidney function compared to the standard fluid? Is the new fluid safe for patients to use? Who can take part in this study? The study is looking for adults (18 and older) who: Are in the ICU and need CRRT treatment as decided by their doctor. Are expected to need this treatment for at least 72 hours. Are willing to participate (or have a legal guardian who agrees). People who are pregnant, have known allergies to the fluid ingredients, or have very low blood pressure that cannot be corrected may not be able to join. How will the research happen? This is a "double-blind" study involving 220 participants across 15 hospitals. This means neither the patients nor the doctors will know which fluid is being used until the study is over. Participants will be put into one of two groups by a computer: Group 1 (New Fluid): Receives the blood purification fluid that has phosphate already in it. Group 2 (Standard Fluid): Receives the standard fluid that does not have phosphate. What will participants have to do? Receive Treatment: Participants will receive their assigned fluid during their normal CRRT care for up to 7 days. Blood Tests: Doctors will take regular blood samples to check mineral levels and kidney health. Monitoring: The medical team will closely watch participants for any side effects or safety concerns. Follow-up: There will be a safety check-up 7 days after the treatment ends. Possible Benefits and Risks The new fluid may help prevent low phosphate levels, which could help with recovery. However, as with any medical treatment, there is a risk of side effects or electrolyte imbalances. The research team will monitor every participant 24/7 to ensure their safety.

Timeline

Start

2026-05-01

Primary completion

2027-12-31

Completion

2028-06-30

Publications

• Results Crowley KE, DeGrado JR, Charytan DM. Serum glucose and phosphorus concentrations during continuous renal replacement therapy using commercial replacement solutions with or without phosphorus. Hemodial Int. 2020 Jul;24(3):330-334. doi: 10.1111/hdi.12834. Epub 2020 Apr 29.
• Results Pistolesi V, Zeppilli L, Polistena F, Sacco MI, Pierucci A, Tritapepe L, Regolisti G, Fiaccadori E, Morabito S. Preventing Continuous Renal Replacement Therapy-Induced Hypophosphatemia: An Extended Clinical Experience with a Phosphate-Containing Solution in the Setting of Regional Citrate Anticoagulation. Blood Purif. 2017;44(1):8-15. doi: 10.1159/000453443. Epub 2017 Feb 21.
• Results Broman M, Carlsson O, Friberg H, Wieslander A, Godaly G. Phosphate-containing dialysis solution prevents hypophosphatemia during continuous renal replacement therapy. Acta Anaesthesiol Scand. 2011 Jan;55(1):39-45. doi: 10.1111/j.1399-6576.2010.02338.x. Epub 2010 Oct 29.
• Results Godaly G, Carlsson O, Broman M. Phoxilium((R)) reduces hypophosphataemia and magnesium supplementation during continuous renal replacement therapy. Clin Kidney J. 2016 Apr;9(2):205-10. doi: 10.1093/ckj/sfv133. Epub 2015 Dec 19.
• Results Pistolesi V, Zeppilli L, Fiaccadori E, Regolisti G, Tritapepe L, Morabito S. Hypophosphatemia in critically ill patients with acute kidney injury on renal replacement therapies. J Nephrol. 2019 Dec;32(6):895-908. doi: 10.1007/s40620-019-00648-5. Epub 2019 Sep 12.
• Results Lim C, Tan HK, Kaushik M. Hypophosphatemia in critically ill patients with acute kidney injury treated with hemodialysis is associated with adverse events. Clin Kidney J. 2017 Jun;10(3):341-347. doi: 10.1093/ckj/sfw120. Epub 2017 Jan 5.
• Results Hendrix RJ, Hastings MC, Samarin M, Hudson JQ. Predictors of Hypophosphatemia and Outcomes during Continuous Renal Replacement Therapy. Blood Purif. 2020;49(6):700-707. doi: 10.1159/000507421. Epub 2020 Apr 22.
• Results Demirjian S, Teo BW, Guzman JA, Heyka RJ, Paganini EP, Fissell WH, Schold JD, Schreiber MJ. Hypophosphatemia during continuous hemodialysis is associated with prolonged respiratory failure in patients with acute kidney injury. Nephrol Dial Transplant. 2011 Nov;26(11):3508-14. doi: 10.1093/ndt/gfr075. Epub 2011 Mar 7.
• Results Pasko DA, Mottes TA, Mueller BA. Pre dialysis of blood prime in continuous hemodialysis normalizes pH and electrolytes. Pediatr Nephrol. 2003 Nov;18(11):1177-83. doi: 10.1007/s00467-003-1258-2. Epub 2003 Oct 2.
• Results Yessayan L, Yee J, Frinak S, Szamosfalvi B. Continuous Renal Replacement Therapy for the Management of Acid-Base and Electrolyte Imbalances in Acute Kidney Injury. Adv Chronic Kidney Dis. 2016 May;23(3):203-10. doi: 10.1053/j.ackd.2016.02.005.

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