Ultrasound-Guided Microbubble Removal and Filter Lifespan During CRRT: A Pilot Crossover Study

NCT ID: NCT07005531

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-06-29

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.

Conditions

Acute Kidney Injury; Continuous Renal Replacement Therapy (CRRT); Filter Clotting; Microbubbles; Ultrasound-Guided Microbubble Removal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Conventional Priming Group

CRRT circuits are primed using the standard visual inspection and manual bubble removal method without ultrasound guidance.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ultrasound-Guided Microbubble Removal Group

CRRT circuits are primed with real-time ultrasound monitoring to detect and guide the removal of residual microbubbles before treatment.

Group Type: EXPERIMENTAL

Ultrasound-Guided Microbubble Clearance During Circuit Priming

Intervention Type: PROCEDURE

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.

Interventions

Ultrasound-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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Qiancheng Xu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Qiancheng Xu

Role: CONTACT

qianchengxu@wnmc.edu.cn

86-18297529106

Other Identifiers

202581

Identifier Type: -

Identifier Source: org_study_id