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Renal Failure , ChronicUS-CVVHDFNCT07397663

Ultrasound-Based Prediction of Hemodynamic Instability During CVVHDF Initiation

An observational study of Renal Failure , Chronic and Intradialytic Hypotension, run by Bursa Yuksek Ihtisas Training and Research Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This prospective observational study aims to evaluate the ability of transthoracic echocardiographic and bedside ultrasonographic parameters to predict intradialytic hypotension and hemodynamic instability at the initiation of continuous venovenous hemodiafiltration (CVVHDF) in adult intensive care unit patients. Read more about this study

Who is it for?
Ages 18 years and older
How many people
80 participants
Where
No sites listed yet
Study dates
10 Feb 2026to 10 Feb 2027
How long will I take part?
1 Year
Phase
Observational
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

Study population: The study population consists of adult patients (aged 18 years and older) admitted to the intensive care unit of a tertiary care academic hospital who have a clinical indication for continuous venovenous hemodiafiltration (CVVHDF). All participants are critically ill and require renal replacement therapy as part of standard clinical care. Transthoracic echocardiography and bedside ultrasonographic and hemodynamic assessments are performed as part of routine intensive care evaluation and are recorded for observational purposes only. No healthy volunteers are included in this study. Written informed consent is obtained from the patients' legal representatives prior to study inclusion.

Who may be able to join

  • Adult patients (≥18 years) admitted to the intensive care unit
  • Indication for continuous venovenous hemodiafiltration
  • Adequate transthoracic echocardiographic image quality
  • Written informed consent obtained from legal representatives

Who cannot join

  • Acute coronary syndrome
  • Severe valvular heart disease or pericardial effusion
  • Significant arrhythmias interfering with Doppler measurements
  • Presence of pacemaker, ICD, or ventricular assist device
  • Poor echocardiographic imaging window
  • Life expectancy less than 24 hours

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

musa h UÇAR contact

+905456934995

ucarharunmusa@gmail.com

About this study

Official title: Prediction of Intradialytic Hypotension at the Initiation of Continuous Venovenous Hemodiafiltration Using Multimodal Ultrasonographic and Hemodynamic Parameters in Intensive Care Unit Patients

This prospective observational study aims to evaluate the ability of transthoracic echocardiographic and bedside ultrasonographic parameters to predict intradialytic hypotension and hemodynamic instability at the initiation of continuous venovenous hemodiafiltration (CVVHDF) in adult intensive care unit patients.

Read the detailed description

In critically ill patients requiring renal replacement therapy, continuous venovenous hemodiafiltration (CVVHDF) is frequently preferred due to better hemodynamic tolerance. However, initiation of CVVHDF may still lead to unpredictable intradialytic hypotension, fluid requirement, or vasopressor/inotrope support.

Bedside transthoracic echocardiography and ultrasonography provide non-invasive assessment of cardiac function, preload responsiveness, and venous congestion. Parameters such as left ventricular outflow tract velocity time integral (LVOT VTI), mitral annular plane systolic excursion (MAPSE), tricuspid annular plane systolic excursion (TAPSE), pulse pressure variation (PPV), renal resistive index (RRI), inferior vena cava (IVC) diameter, and venous excess ultrasound score (VExUS) may help predict hemodynamic tolerance to dialysis.

This study aims to evaluate the predictive value of these multimodal ultrasonographic and hemodynamic parameters for intradialytic hypotension and hemodynamic support requirement during the first 60 minutes of CVVHDF initiation.

Keywords
Intradialytic Hypotension, LVOT VTI, CVVHD, Renal Resistive Index, Echocardiography, VExUS
Medical subject headings
Renal Insufficiency, Chronic, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemodynamic Instability During CVVHDF Initiation

    Occurrence of hypotension (mean arterial pressure <65 mmHg), requirement for fluid bolus (≥500 mL), or initiation/increase of vasopressor or inotrope support within the first 60 minutes after CVVHDF initiation.

    Measured: First 60 minutes after CVVHDF initiation

Secondary outcomes (7)

  1. LVOT Velocity Time Integral

    Measurement of left ventricular outflow tract velocity time integral obtained by transthoracic echocardiography before dialysis initiation.

    Measured: Before CVVHDF initiation

  2. Mitral Annular Plane Systolic Excursion (MAPSE)

    Measurement of mitral annular plane systolic excursion obtained by M-mode transthoracic echocardiography in the apical four-chamber view to assess left ventricular longitudinal systolic function prior to CVVHDF initiation.

    Measured: Before CVVHDF initiation

  3. Tricuspid Annular Plane Systolic Excursion (TAPSE)

    Measurement of tricuspid annular plane systolic excursion obtained by M-mode transthoracic echocardiography in the apical four-chamber view to evaluate right ventricular systolic function prior to CVVHDF initiation.

    Measured: Before CVVHDF initiation

  4. Pulse Pressure Variation (PPV)

    Calculation of pulse pressure variation derived from invasive arterial blood pressure waveform analysis in mechanically ventilated patients to assess dynamic preload responsiveness prior to CVVHDF initiation.

    Measured: Before CVVHDF initiation

  5. Renal Resistive Index (RRI)

    Measurement of the Renal Resistive Index (RRI), obtained by pulsed-wave Doppler ultrasonography of the segmental or interlobar renal arteries, to evaluate intrarenal vascular resistance and renal perfusion prior to initiation of continuous veno-venous hemodiafiltration (CVVHDF). The Renal Resistive Index is calculated as (peak systolic velocity - end diastolic velocity) / peak systolic velocity, with values ranging from 0 to 1. Values greater than 0.7 are considered indicative of increased intrarenal vascular resistance and poorer renal perfusion (worse outcome).

    Measured: Before CVVHDF initiation

  6. Inferior Vena Cava Diameter

    Ultrasonographic measurement of inferior vena cava diameter obtained from the subcostal long-axis view to assess intravascular volume status prior to CVVHDF initiation.

    Measured: Before CVVHDF initiation

  7. Venous Excess Ultrasound Score (VExUS)

    Assessment of systemic venous congestion using the Venous Excess Ultrasound Score (VExUS) prior to initiation of continuous veno-venous hemodiafiltration (CVVHDF). The Venous Excess Ultrasound Score is a grading system ranging from 0 to 3, incorporating inferior vena cava diameter and Doppler flow patterns of the hepatic, portal, and intrarenal veins. Higher scores indicate more severe systemic venous congestion and are associated with worse clinical status.

    Measured: Before CVVHDF initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start10 Feb 2026 (estimated)
  3. Primary completion10 Feb 2027 (estimated)
  4. Study completion10 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07397663
Sponsor's protocol ID
KAEK/2026.01.24
Acronym
US-CVVHDF
Status last verified
Feb 2026
First submitted
2 Feb 2026
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Cheong I. Unconventional Echocardiographic Techniques for LVOT VTI Measurement in Critical Care Settings. J Clin Ultrasound. 2025 Jul-Aug;53(6):1418-1424. doi: 10.1002/jcu.24007. Epub 2025 Apr 12.

    PubMed 40219729

  • Assavapokee T, Rola P, Assavapokee N, Koratala A. Decoding VExUS: a practical guide for excelling in point-of-care ultrasound assessment of venous congestion. Ultrasound J. 2024 Nov 19;16(1):48. doi: 10.1186/s13089-024-00396-z.

    PubMed 39560910

  • Monnet X, Shi R, Teboul JL. Prediction of fluid responsiveness. What's new? Ann Intensive Care. 2022 May 28;12(1):46. doi: 10.1186/s13613-022-01022-8.

    PubMed 35633423

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Failure , Chronic and Intradialytic Hypotension, run by Bursa Yuksek Ihtisas Training and Research Hospital.

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 6 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 13 Feb 2026. 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 musa h UÇAR (+905456934995, ucarharunmusa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemodynamic Instability During CVVHDF Initiation (time frame: First 60 minutes after CVVHDF initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07397663, which also lists 3 linked publications.

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 13 Feb 2026.

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