Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07397663

Ultrasound-Based Prediction of Hemodynamic Instability During CVVHDF Initiation

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Hemodynamic Instability During CVVHDF Initiation

    Time frame: First 60 minutes after 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.

Secondary outcomes

  1. LVOT Velocity Time Integral

    Time frame: Before CVVHDF initiation

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

  2. Mitral Annular Plane Systolic Excursion (MAPSE)

    Time frame: Before CVVHDF initiation

    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.

  3. Tricuspid Annular Plane Systolic Excursion (TAPSE)

    Time frame: Before CVVHDF initiation

    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.

  4. Pulse Pressure Variation (PPV)

    Time frame: Before CVVHDF initiation

    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.

  5. Renal Resistive Index (RRI)

    Time frame: Before CVVHDF initiation

    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).

  6. Inferior Vena Cava Diameter

    Time frame: Before CVVHDF initiation

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

  7. Venous Excess Ultrasound Score (VExUS)

    Time frame: Before CVVHDF initiation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

musa h UÇAR

CONTACT

[email protected]

+905456934995

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

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

Acronym: US-CVVHDF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.