Acute Kidney Injury, Continuous Renal Replacement Therapy (CRRT), Filter Clotting, Microbubbles, Ultrasound-Guided Microbubble Removal
Conditions
Keywords
Continuous Renal Replacement Therapy (CRRT), Filter Lifespan, Microbubbles, Ultrasound Guidance, Filter Clotting, Circuit Priming, Critical Care, Randomized Crossover Trial
Brief summary
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.
Interventions
PROCEDUREUltrasound-Guided Microbubble Clearance During Circuit Priming
CRRT 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.
Sponsors
First Affiliated Hospital of Wannan Medical College
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Filter Lifespan | For each CRRT session, up to a maximum of 72 hours per session. | 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 | Peri-procedural (from initiation to completion of each CRRT session) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Filter Clotting | For each CRRT session, up to a maximum of 72 hours per session. | Number and proportion of CRRT circuits with filter clotting events requiring early replacement. |
| 28-Day Survival Rate | Day 28 after enrollment. | Proportion of patients surviving at 28 days after enrollment. |
Contacts
Primary ContactQiancheng Xu
Outcome results
None listed