Echocardiographic Parameters for Hemodynamic Support During CVVHDF (NCT07019051) | Clinical Trial Compass
CompletedNot Applicable
Echocardiographic Parameters for Hemodynamic Support During CVVHDF
Turkey (Türkiye)40 participantsStarted 2025-06-23
Plain-language summary
This prospective observational study aims to evaluate whether transthoracic echocardiographic parameters-Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI), Mitral Annular Plane Systolic Excursion (MAPSE), Tricuspid Annular Plane Systolic Excursion (TAPSE), S' wave velocity, and E/e' ratio-can predict hemodynamic instability at the initiation of sustained low-efficiency daily dialysis (SVVHDF) in intensive care unit (ICU) patients. The study will include adult patients requiring SVVHDF, and echocardiographic measurements will be performed prior to dialysis. The primary outcome is the need for hemodynamic support (vasopressors/inotropes or fluid resuscitation) or development of hypotension within the first 60 minutes of dialysis. The study aims to identify which of these parameters best predict the need for hemodynamic intervention, with the goal of supporting individualized dialysis planning and safer fluid management in critically ill patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Admission to the intensive care unit (ICU)
* Clinical indication for initiation of continuous veno-venous hemodiafiltration (CVVHDF)
* Ability to obtain adequate transthoracic echocardiographic (TTE) images prior to CVVHDF
* Written informed consent obtained from the patient's legal representative
Exclusion Criteria:
* Acute coronary syndrome, severe valvular disease, or pericardial effusion affecting cardiac function
* Cardiac arrhythmias such as atrial fibrillation or ventricular tachycardia that interfere with accurate Doppler measurements
* Presence of cardiac devices such as pacemakers, LVADs, or implantable cardioverter defibrillators (ICDs)
* Poor echocardiographic window due to severe lung disease or chest wall abnormalities
* Estimated life expectancy \<24 hours or do-not-resuscitate (DNR) orders in place
* Inability to obtain informed consent due to lack of legal representative
* Transfer to another facility before CVVHDF initiation or change in renal replacement strategy (e.g., switch to peritoneal dialysis)
* Incomplete echocardiographic measurement due to technical limitations
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of Hemodynamic Instability Within the First 60 Minutes of CVVHDF and Its Association With Pre-Dialysis LVOT VTI
Timeframe: Within the first 60 minutes of CVVHDF initiation
Trial details
NCT IDNCT07019051
SponsorKanuni Sultan Suleyman Training and Research Hospital