Acute Kidney InjuryNCT07005531
Ultrasound-Guided Microbubble Removal and Filter Lifespan During CRRT: A Pilot Crossover Study
A study testing Ultrasound-Guided Microbubble Clearance During Circuit Priming in people with Acute Kidney Injury and Continuous Renal Replacement Therapy (CRRT), run by First Affiliated Hospital of Wannan Medical College.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Continuous Renal Replacement Therapy (CRRT), Filter Clotting
- What is being tested?
- Ultrasound-Guided Microbubble Clearance During Circuit Priming
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Ultrasound-Guided Microbubble Clearance During CRRT Circuit Priming on Filter Lifespan: A Randomized Crossover Pilot Trial
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.
Read more
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.
- Conditions
- Acute Kidney Injury, Continuous Renal Replacement Therapy (CRRT), Filter Clotting, Microbubbles, Ultrasound-Guided Microbubble Removal
- Being tested
- Ultrasound-Guided Microbubble Clearance During Circuit Priming
- Keywords
- Continuous Renal Replacement Therapy (CRRT), Filter Lifespan, Microbubbles, Ultrasound Guidance, Filter Clotting, Circuit Priming, Critical Care, Randomized Crossover Trial
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Microbubble Clearance During Circuit PrimingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Priming Group | No intervention | CRRT circuits are primed using the standard visual inspection and manual bubble removal method without ultrasound guidance. |
| Ultrasound-Guided Microbubble Removal Group | Experimental | CRRT circuits are primed with real-time ultrasound monitoring to detect and guide the removal of residual microbubbles before treatment. Receives: Procedure: Ultrasound-Guided Microbubble Clearance During Circuit Priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: For each CRRT session, up to a maximum of 72 hours per session.
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.
Measured: Peri-procedural (from initiation to completion of each CRRT session)
Secondary outcomes (2)
Incidence of Filter Clotting
Number and proportion of CRRT circuits with filter clotting events requiring early replacement.
Measured: For each CRRT session, up to a maximum of 72 hours per session.
28-Day Survival Rate
Proportion of patients surviving at 28 days after enrollment.
Measured: Day 28 after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion29 Jun 2026 (estimated)
- Study completion29 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiancheng Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005531
- Sponsor's protocol ID
- 202581
- Status last verified
- Jun 2025
- First submitted
- 18 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultrasound-Guided Microbubble Clearance During CRRT Circuit Priming on Filter Lifespan: A Randomized Crossover Pilot Trial
- ClinicalTrials.gov ID
- NCT07005531
- Acronym / sponsor ID
- 202581
- Conditions
- Acute Kidney Injury, Continuous Renal Replacement Therapy (CRRT), Filter Clotting, Microbubbles, Ultrasound-Guided Microbubble Removal
- Keywords
- Continuous Renal Replacement Therapy (CRRT), Filter Lifespan, Microbubbles, Ultrasound Guidance, Filter Clotting, Circuit Priming, Critical Care, Randomized Crossover Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 29 Jun 2026 (estimated)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Priming Group | No intervention | –CRRT circuits are primed using the standard visual inspection and manual bubble removal method without ultrasound guidance. |
| Ultrasound-Guided Microbubble Removal Group | Experimental | Procedure: Ultrasound-Guided Microbubble Clearance During Circuit PrimingCRRT circuits are primed with real-time ultrasound monitoring to detect and guide the removal of residual microbubbles before treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Microbubble Clearance During Circuit PrimingCRRT 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. | Procedure or surgery | Ultrasound-Guided Microbubble Removal Group |
Primary outcome
Filter Lifespan
Time frame: 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
Time frame: 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.
2 secondary outcomes
Incidence of Filter Clotting
Time frame: For each CRRT session, up to a maximum of 72 hours per session.
28-Day Survival Rate
Time frame: Day 28 after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Microbubble Clearance During Circuit Priming in people with Acute Kidney Injury and Continuous Renal Replacement Therapy (CRRT), run by First Affiliated Hospital of Wannan Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiancheng Xu (86-18297529106, qianchengxu@wnmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Filter Lifespan (time frame: For each CRRT session, up to a maximum of 72 hours per session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.