Phosphate-Containing Replacement Fluid for Patients Undergoing CRRT

Condition(s) studied

Investigational drug(s) / intervention(s)

Phosphate-containing Replacement Fluid: Phosphate-containing Replacement Fluid is an investigational Class 2.3 modified chemical drug approved by the NMPA (No. 2021LP00824). It is a premixed, electrolyte-balanced replacement fluid containing phosphorus. The solution is administered via the extracorporeal circuit during Continuous Renal Replacement Therapy (CRRT). The dosage and flow rate are standardized according to the subject's body weight and clinical requirements (typically 25-35 mL/kg/h).

Standard Phosphate-free Replacement Fluid: A marketed phosphate-free replacement fluid (standard of care). Administration via extracorporeal circuit with doses identical to the experimental group. Treatment is expected for 72 hours, up to a maximum of 7 days, or until CRRT is clinically terminated. This comparator evaluates the efficacy of the phosphate-containing solution in preventing treatment-induced hypophosphatemia.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Serum Creatinine at 72 Hours — 72 hours
  Percentage change in serum creatinine from baseline to 72 hours to evaluate the non-inferiority of the phosphate-containing fluid in solute clearance.
• Incidence of Hypophosphatemia Within 72 Hours — Up to 72 hours
  Percentage of participants with any measured serum phosphorus \< 0.81 mmol/L during the 72-hour treatment window.

Trial sites (15)

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