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Not yet recruiting NCT07397663

Ultrasound-Based Prediction of Hemodynamic Instability During CVVHDF Initiation

— Observational Renal Failure , Chronic Intradialytic Hypotension Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Renal Failure , Chronic, Intradialytic Hypotension, Critical Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • Hemodynamic Instability During CVVHDF Initiation [Time frame: First 60 minutes after CVVHDF initiation]
Secondary outcome measures (7)
  • LVOT Velocity Time Integral [Time frame: Before CVVHDF initiation]
  • Mitral Annular Plane Systolic Excursion (MAPSE) [Time frame: Before CVVHDF initiation]
  • Tricuspid Annular Plane Systolic Excursion (TAPSE) [Time frame: Before CVVHDF initiation]
  • Pulse Pressure Variation (PPV) [Time frame: Before CVVHDF initiation]
  • Renal Resistive Index (RRI) [Time frame: Before CVVHDF initiation]
  • Inferior Vena Cava Diameter [Time frame: Before CVVHDF initiation]
  • Venous Excess Ultrasound Score (VExUS) [Time frame: Before CVVHDF initiation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 35633423

Identifiers

NCT: NCT07397663 · KAEK/2026.01.24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗