Ultrasound-Based Prediction of Hemodynamic Instability During CVVHDF Initiation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBursa Yuksek Ihtisas Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Acute coronary syndrome
Severe valvular heart disease or pericardial effusion
Significant arrhythmias interfering with Doppler measurements
Presence of pacemaker, ICD, or ventricular assist device
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
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.
Time frame
First 60 minutes after CVVHDF initiationSecondary outcomes
1
LVOT Velocity Time Integral
Measurement of left ventricular outflow tract velocity time integral obtained by transthoracic echocardiography before dialysis initiation.
Time frame
Before CVVHDF initiation2
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.
Time frame
Before CVVHDF initiation3
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.
Time frame
Before CVVHDF initiation4
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.
Time frame
Before CVVHDF initiationLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bursa Yuksek Ihtisas Training and Research Hospital
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: