Fluid Balance Guided by Modified Venous Excess Ultrasonography Versus Standard Care in Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy

NCT07346118 | Not Yet Recruiting

• 1 other identifier: 0449/2568
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this randomised controlled trial is to compare the cumulative fluid balance over the first 72 h following inclusion guided by mVExUS versus standard of care in critically ill patients with acute kidney injury receiving CRKT . It will also compare the proportion of CRRT-related complications-including intradialytic hypotension and arrhythmias-between patients managed with mVExUS-guided fluid management and those receiving standard care. The main questions it aims to answer are: Does fluid removal rate guided by mVExUS will reduce cumulative fluid balance over the course of the first 72 h of CRRT in ICU patients compared to standard care Participants will: Get fluid assessment by mVExUS protocol or a strandard care every 8 hours for 72 hours

Conditions

Fluid Balance; AKI - Acute Kidney Injury; VExUS; Acute Circulatory Failure; Continuous Renal Replacement Therapy (CRRT); Passive Leg Raising; Biomarkers / Blood

Keywords

Acute kidney injury; Fluid balance; Acute circulatory failure; Continuous kidney replacement therapy; mVExUS; Modified Venous Excess Ultrasound; Passive leg raising; Biomarker

Outcome Measures

Primary Outcomes (1)

• 72-hour cumulative fluid balance between mVExUS-guided management and standard care in critically ill patients with acute kidney injury receiving CRKT.

  In the mVExUS-guided management the fluid removal rate will be guided based on mVExUS ultrasound results. In standard care the fluid removal rate is based on conventionval fluid assessment

  Hour 0, Hour 72

Secondary Outcomes (4)

• 28 and 90-day mortality between mVExUS-guided fluid management compared with standard care

  28 days, 90 days

• AKI sub-phenotypes, categorized by angiopoietin-1, angiopoietin-2, and soluble TNF receptor-1, association with risk of death in critically ill patients with acute kidney injury receiving CRRT

  28 days

• The proportion of CRRT-related complications-including intradialytic hypotension and arrhythmias-between patients managed with mVExUS-guided fluid management and those receiving standard care

  Hour 0, Hour 72

• The difference patterns of fluid accumulation and net ultrafiltration trajectories and correlation with differences in 28-day mortality in critically ill patients with acute kidney injury receiving CRRT

  28 days

Study Arms (2)

mVExUS-guided fluid management

ACTIVE COMPARATOR

Procedure: mVExUS-guided fluid management

Standard care

NO INTERVENTION

Interventions

mVExUS-guided fluid management PROCEDURE

In the intervention arm, mVExUS has to be performed every 24 hours until 72 hours after enrollment. Participants with profile A will have UFNET 0 mL/hr with target fluid balance 0 to +500 mL/day. Patients with profile B will have UFNET 0-20 mL/hr with target fluid balance 0 to -500 mL/day. Patients with profile C will have UFNET 20-40 mL/hr with target fluid balance -500 to -1000 mL/day. Patients with profile D will have UFNET 40-100 mL/hr with target fluid balance neg \>1000 mL/day. This intervention will be combined with serial lactate monitoring in which lactate levels will be measured every 8 h. When the lactate level rises more than 2 or if there is presence of HIRRT (tachycardia, hypotension, mottling or drop in cardiac index), passing leg raising or mini-fluid challenge (crystalloid fluid bolus 200 mL) will be performed to assess fluid responsiveness. If there is fluid responsiveness, UFNET will be stopped. Once lactate is normalized or episode of HIRRT resolved, the UFNET strat

mVExUS-guided fluid management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥ 18 years of age)
• Admitted to ICU
• Acute kidney injury by KDIGO criteria
• Initiated CRRT by at least one of the following indications for RRT initiation:
• Serum potassium ≥ 6.0 mmol/L, or
• pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L, or
• Evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload, or
• Persistent severe AKI (sCr remains \> 50% the value recorded at randomization) for \> 72 hours from randomization
• Participants giving informed consent

You may not qualify if:

• Refuse to participate
• Previous diagnosis of end-stage kidney disease (ESKD) currently on kidney replacement therapy
• Kidney transplant recipient
• Receive RRT before ICU admission within 90 days
• Structural kidney diseases which will interfere with intrarenal doppler ultrasound e.g. renal artery stenosis, autosomal dominant polycystic kidney disease
• Patients with previously known conditions that interfere with portal doppler assessment, namely liver cirrhosis, severe tricuspid regurgitation with structural heart disease or massive ascites.
• Underlying disease process with a life expectancy less than 90 days
• Pregnancy
• Severe cardiac rhythm disturbances (tachyarrhythmia, supraventricular tachycardia)
• Intra-cardiac shunts; Ventricle septal defect, patent foramen ovale, atrial septal defect
• Aortic aneurysm
• Intra-abdominal hypertension (intraabdominal pressure ≥20 mmHg)
• Expected life expectancy \<48 hours
• Receiving extracorporeal membrane oxygenation (ECMO)

Sponsors & Collaborators

• Chulalongkorn University: lead

MeSH Terms

Conditions

Acute Kidney Injury; Shock

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

thanphisit trakarnvanich, Bachelor's Degree

CONTACT

+66896996830; thanphisit2@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a multicentre open-label, randomised, controlled trial with parallel groups and balanced computerized randomisation with a 1:1 ratio

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: January 16, 2026

Record last verified: 2026-01