What is this study about? This study is designed to evaluate whether ultrasound-guided removal of microbubbles during circuit priming in Continuous Renal Replacement Therapy (CRRT) can extend the filter lifespan for critically ill patients who require CRRT. The investigators aim to determine if this technique improves the duration of effective filter use and reduces complications related to filter clotting.
Who can join? Adults (18 years or older) admitted to the Intensive Care Unit (ICU) and diagnosed with acute kidney injury (AKI) or chronic kidney failure (CKD) who require CRRT and are expected to undergo at least two sessions of CRRT treatment.
Participants or their legal representatives must provide signed informed consent.
Who cannot join? Patients with severe coagulation disorders, platelet count \<30×10\^9/L, contraindications to anticoagulation, significant changes in clinical scores or blood tests between CRRT sessions, or any other condition deemed unsuitable by the investigator.
What will happen during the study?
Two Treatment Methods:
Conventional Priming (Control): The CRRT circuit will be primed following the standard visual bubble inspection protocol.
Ultrasound-Guided Priming (Intervention): The circuit will be primed using real-time ultrasound to detect and remove microbubbles from key locations.
Each participant will receive both interventions in random order, separated by a washout period of at least 24 hours.
Safe and Routine Monitoring:
Ultrasound scans will be performed on the filter and circuit to guide microbubble removal.
Standardized CRRT treatment protocols, including filter type and anticoagulation regimen, will be used for all sessions.
Other Data Collection:
Patient information (e.g., age, sex, medical history, APACHE II score) CRRT treatment details (e.g., filter lifespan, filter clotting incidence, coagulation parameters) Monitoring of adverse events and clinical outcomes (including 28-day survival and treatment costs) What are the benefits and risks? Benefits: This study may provide evidence for a simple, non-invasive method to reduce filter clotting, improve CRRT efficiency, and enhance patient outcomes.
Risks: Ultrasound monitoring is non-invasive and does not add risk beyond standard care. All procedures are standard clinical practice.
Your Rights and Safety Voluntary Participation: Participation is voluntary; withdrawal is allowed at any time without affecting clinical care.
Ethical Approval: The study protocol is reviewed and approved by the hospital's ethics committee.
Confidentiality: All personal information and test results will be kept confidential.
Age ≥18 years, regardless of sex;
Admission to the intensive care unit (ICU) with a diagnosis of acute kidney injury (AKI) or chronic kidney disease (CKD) requiring continuous renal replacement therapy (CRRT);
Expected to receive at least two sessions of CRRT;
Written informed consent obtained from the patient or their legally authorized representative.
Presence of severe coagulopathy (such as disseminated intravascular coagulation, DIC) or platelet count <30×10^9/L;
Contraindications to anticoagulation therapy;
Change in APACHE II score >5 points, or changes in coagulation parameters and platelet count exceeding 20% between the two treatment sessions;
Any other condition deemed unsuitable for participation by the investigators.
Crossover
Ultrasound-Guided Microbubble Clearance During Circuit Priming
Procedure/SurgeryCRRT circuits will be primed under real-time ultrasound monitoring. A portable ultrasound probe will be used to scan key points in the circuit and filter to detect and guide the removal of residual microbubbles before treatment. The process is considered complete when three consecutive scans (at 2-minute intervals) show no detectable microbubbles.
Filter Lifespan
Time (in hours) from the start of CRRT treatment to filter failure (defined as filter clotting requiring replacement, or completion of prescribed treatment).
Feasibility of Ultrasound-Guided Microbubble Clearance
Feasibility will be evaluated by the proportion of CRRT sessions in which microbubble clearance is completed according to predefined ultrasound scanning criteria (three consecutive scans at 10-minute intervals without detectable microbubbles). Assessment is based on procedure documentation and saved ultrasound images.
Incidence of Filter Clotting
Number and proportion of CRRT circuits with filter clotting events requiring early replacement.
28-Day Survival Rate
Proportion of patients surviving at 28 days after enrollment.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
