Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 8:50 PM
Study NCT ID:
NCT07019051
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echocardiographic Parameters for Hemodynamic Support During CVVHDF
Sponsor:
Kanuni Sultan Suleyman Training and Research Hospital
Organization:
Study Overview
Official Title:
Predictive Role of Echocardiographic Parameters for Hemodynamic Support Needs During Initiation of Continuous Venovenous Hemodiafiltration in ICU Patients
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This prospective, single-center observational study is designed to investigate the predictive value of specific transthoracic echocardiographic (TTE) parameters in assessing the risk of hemodynamic instability during the initiation of sustained low-efficiency daily dialysis (SVVHDF) in critically ill patients. The primary focus is to determine whether measurements obtained immediately before dialysis-namely LVOT VTI, MAPSE, TAPSE, S', and E/e'-can identify patients at risk of hypotension or the need for hemodynamic support within the first hour of treatment.
All echocardiographic assessments will be performed by certified intensive care specialists or cardiologists using standard parasternal and apical windows. The parameters to be evaluated include:
LVOT VTI (Left Ventricular Outflow Tract Velocity-Time Integral):
Measured via pulsed wave Doppler from the apical 5-chamber view, this value reflects stroke volume and overall cardiac output. A low LVOT VTI may indicate hypovolemia or decreased systolic function.
MAPSE (Mitral Annular Plane Systolic Excursion):
Obtained using M-mode in the apical 4-chamber view by measuring the displacement of the mitral annulus during systole. It is an index of longitudinal left ventricular systolic function; values \<10 mm may suggest early left ventricular dysfunction.
TAPSE (Tricuspid Annular Plane Systolic Excursion):
Also measured with M-mode in the apical 4-chamber view, TAPSE reflects right ventricular systolic function. Values \<17 mm are indicative of right ventricular dysfunction.
S' (S Prime) Wave:
Using tissue Doppler imaging (TDI) at the mitral and/or tricuspid annulus, this parameter evaluates longitudinal systolic myocardial velocity. Reduced S' values suggest impaired ventricular contractility.
E/e' Ratio:
Calculated from pulsed Doppler and TDI values, this ratio estimates left ventricular filling pressures. An E/e' \>15 is associated with elevated filling pressure, while \<8 suggests normal filling.
Patients will be monitored for hemodynamic instability within the first 60 minutes following SVVHDF initiation. The primary hemodynamic outcomes include:
Hypotension: Defined as a mean arterial pressure (MAP) \<65 mmHg or a ≥20% decrease in MAP compared to baseline values prior to dialysis initiation.
Need for Vasopressor or Inotrope Support: Initiation of medications such as norepinephrine, dopamine, or dobutamine during the first hour of dialysis.
Need for Additional Fluid Resuscitation: Defined as administration of ≥500 mL crystalloid or colloid solution within 60 minutes due to clinical signs of volume depletion.
Clinical decisions related to dialysis and hemodynamic management will be made solely by the treating physicians, with study investigators collecting data in an observational capacity. All echocardiographic and hemodynamic data will be anonymized and stored securely for statistical analysis.
This study aims to identify echocardiographic biomarkers that can improve the safety and personalization of dialysis management in ICU settings, with potential applications extending to chronic dialysis centers in the future.
All echocardiographic assessments will be performed by certified intensive care specialists or cardiologists using standard parasternal and apical windows. The parameters to be evaluated include:
LVOT VTI (Left Ventricular Outflow Tract Velocity-Time Integral):
Measured via pulsed wave Doppler from the apical 5-chamber view, this value reflects stroke volume and overall cardiac output. A low LVOT VTI may indicate hypovolemia or decreased systolic function.
MAPSE (Mitral Annular Plane Systolic Excursion):
Obtained using M-mode in the apical 4-chamber view by measuring the displacement of the mitral annulus during systole. It is an index of longitudinal left ventricular systolic function; values \<10 mm may suggest early left ventricular dysfunction.
TAPSE (Tricuspid Annular Plane Systolic Excursion):
Also measured with M-mode in the apical 4-chamber view, TAPSE reflects right ventricular systolic function. Values \<17 mm are indicative of right ventricular dysfunction.
S' (S Prime) Wave:
Using tissue Doppler imaging (TDI) at the mitral and/or tricuspid annulus, this parameter evaluates longitudinal systolic myocardial velocity. Reduced S' values suggest impaired ventricular contractility.
E/e' Ratio:
Calculated from pulsed Doppler and TDI values, this ratio estimates left ventricular filling pressures. An E/e' \>15 is associated with elevated filling pressure, while \<8 suggests normal filling.
Patients will be monitored for hemodynamic instability within the first 60 minutes following SVVHDF initiation. The primary hemodynamic outcomes include:
Hypotension: Defined as a mean arterial pressure (MAP) \<65 mmHg or a ≥20% decrease in MAP compared to baseline values prior to dialysis initiation.
Need for Vasopressor or Inotrope Support: Initiation of medications such as norepinephrine, dopamine, or dobutamine during the first hour of dialysis.
Need for Additional Fluid Resuscitation: Defined as administration of ≥500 mL crystalloid or colloid solution within 60 minutes due to clinical signs of volume depletion.
Clinical decisions related to dialysis and hemodynamic management will be made solely by the treating physicians, with study investigators collecting data in an observational capacity. All echocardiographic and hemodynamic data will be anonymized and stored securely for statistical analysis.
This study aims to identify echocardiographic biomarkers that can improve the safety and personalization of dialysis management in ICU settings, with potential applications extending to chronic dialysis centers in the future.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: