ClinicalTrials.gg
RecruitingNCT07346118mVExUS-CRRTUpdated Oct 5, 2026

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

An interventional study of mVExUS-guided fluid management in AKI - Acute Kidney Injury, Fluid Balance and Acute Circulatory Failure, sponsored by Chulalongkorn University. Recruiting at 2 sites in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment

Updated Oct 5, 2026Now RecruitingFirst site in Thailand+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

After enrollment, the participants have to be randomized within 1 h. 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 strategy has to be restored.

The CRRT technique (haemodialysis, haemofiltration, haemodiafiltration) will be left at the discretion of the treating team. CRRT dose (i.e. dialysate or reinfusion fluids flow rate) will be prescribed at 25-30 ml/kg/hr according to the KDIGO guideline. CRRT dose and UFNET will be indexed to the patient's body weight, and in patients with a body mass index at 30 kg/m2, to the adjusted body weight (calculated as ideal body weight to which will be added 40% of the difference between the actual body weight and the ideal body weight - Du Bois formula). Choice of extra-corporeal circuit anticoagulation (heparin, citrate or none) and implantation site of CRRT catheters will be left at the discretion of the treating physician.

Vasopressors will be titrated as per unit-based protocols to maintain the mean arterial pressure within the bounds prescribed by the physician in charge (most frequently between 65 and 75 mmHg). Indications and category of vasopressors and inotropes will be left at the discretion of the treating team. The diuretic will be stopped once the patient is enrolled.

02

Conditions studied

  • AKI - Acute Kidney Injury
  • Fluid Balance
  • Acute Circulatory Failure
  • Continuous Renal Replacement Therapy (CRRT)
  • VExUS
  • 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
03

In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's planned enrollment of 126 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
126 participants (estimated)

Study arms

  • Active comparator
    mVExUS-guided fluid management

    Procedure: mVExUS-guided fluid management

  • No intervention
    Standard care

Interventions

  • ProceduremVExUS-guided fluid management

    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

06

What researchers measure

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

    Time frame: Hour 0, Hour 72

Secondary outcomes

  1. 28 and 90-day mortality between mVExUS-guided fluid management compared with standard care

    Time frame: 28 days, 90 days

  2. 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

    Time frame: 28 days

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

    Time frame: Hour 0, Hour 72

  4. 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

    Time frame: 28 days

07

Study locations

1 of 2 sites recruiting
  • Vajira Hospital, Navamindradhiraj University
    Bangkok, 10300, Thailand
    Not yet recruiting
  • King Chulalongkorn Memorial Hospital
    Bangkok, 10330, Thailand
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — The datasets used and/or analysed will be available from the corresponding author on reasonable request.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2029, 29 months later.

Of 249 non-industry interventional studies with no phase under Acute Kidney Injury, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 29 months is close to that.

Counting every sponsor, half of 267 studies reached it within 26 months; a quarter within 12 and three quarters within 44.

Start moved once since we started tracking on Sep 25, 2026: Jul 2026 → Sep 2026, on Oct 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 24, 2025
First posted
Jan 16, 2026
StartEst.
Sep 30, 2026was Jul 2026
Primary completionEst.
Mar 1, 2029
CompletionEst.
May 1, 2029
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 5, 2026
Sites
2 sites added — first site in Thailand
Show 2 added (2 Thailand)
  • Vajira Hospital, Navamindradhiraj University · Bangkok, Thailand
  • King Chulalongkorn Memorial Hospital · Bangkok, Thailand
Oct 5, 2026
Start date
Jul 1, 2026→Sep 30, 2026
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Not yet recruiting→Recruiting
    2 sites added — first site in Thailand
    Show 2 added (2 Thailand)
    • Vajira Hospital, Navamindradhiraj University · Bangkok, Thailand
    • King Chulalongkorn Memorial Hospital · Bangkok, Thailand
    Start date Jul 1, 2026→Sep 30, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07346118
Responsible party
Sponsor
First posted
Jan 16, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Mar 1, 2029 (estimated)
Completion
May 1, 2029 (estimated)
Last update
Oct 5, 2026

Study contacts

thanphisit trakarnvanich, Bachelor's Degree
Contact
thanphisit2@hotmail.com
+66896996830

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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