Phosphate-Containing Replacement Fluid for Patients Undergoing CRRT

Starting soon · Phase 3

Conditions studied: Acute Kidney Injury, Sepsis, Critically Ill Patients Requiring Continuous Renal Replacement Therapy

In brief

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.

Key facts

Study ID

NCT07550894

Run by

Sun Yat-sen University

People needed

220

Starts

2026-05-01

Expected to finish

2028-06-30

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all of the following criteria to be eligible for the study:
• Aged 18 years or older, regardless of gender.
• Meet the clinical indications for Continuous Renal Replacement Therapy (CRRT) as defined by the "Standard Operating Procedures for Blood Purification (2021 Edition)" and assessed by a qualified nephrologist or intensive care physician.
• Expected continuous blood purification duration is 72 hours or longer.
• The participant or their legal guardian has a full understanding of the purpose and significance of the trial, voluntarily agrees to participate and comply with the study procedures, and has signed the written Informed Consent Form (ICF).

You may not qualify if…

• Participants meeting any of the following criteria will be excluded from the study:
• Known allergy to any component of the investigational drug, or individuals with an allergic constitution.
• Inability to establish suitable vascular access for CRRT.
• Persistent hypotension (Systolic Blood Pressure < 90 mmHg or Mean Arterial Pressure < 65 mmHg) that is difficult to correct, unless judged by the investigator as potentially correctable with intervention.
• Presence of malignant tumors with systemic metastasis (except for those who previously underwent radical surgery without recurrence).
• Pregnant or breastfeeding women.
• Receipt of any form of renal replacement therapy (RRT) or blood purification treatment within 24 hours prior to screening.
• Receipt of peritoneal dialysis within 24 hours prior to screening.
• Participation in any other clinical trial involving investigational drugs or devices within 1 month prior to screening.
• Any other condition or reason that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.

Where it is running

• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China
• The First Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China
• The Third Affiliated Hospital, Sun Yat-Sen Unive — Guangzhou, Guangdong, China
• Zhujiang Hospital, Southern Medical University — Guangzhou, Guangdong, China
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, Henan, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China
• Jiangsu Province Hospital — Nanjing, Jiangsu, China
• The First Affiliated Hospital of Xi 'An Jiaotong University — Xi'an, Shaanxi, China
• Renji Hospital, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China
• Shanxi Provincial People's Hospital — Taiyuan, Shanxi, China
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China
• West China Hospital of Sichuan University — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.