Echocardiographic Parameters for Hemodynamic Support During CVVHDF

NCT07019051 | Completed

• 1 other identifier: lvot vti AKIN
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

• Occurrence of Hemodynamic Instability Within the First 60 Minutes of CVVHDF and Its Association With Pre-Dialysis LVOT VTI

  Hemodynamic instability will be recorded within the first 60 minutes after initiation of continuous veno-venous hemodiafiltration (CVVHDF). Instability is defined by the occurrence of any of the following: Mean arterial pressure (MAP) \< 65 mmHg, ≥30% decrease in MAP from pre-CVVHDF baseline, Initiation of vasopressors or inotropes, Administration of ≥500 mL of intravenous fluid bolus for resuscitation. Each patient's Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI) will be measured by transthoracic echocardiography prior to CVVHDF initiation.

  Within the first 60 minutes of CVVHDF initiation

Secondary Outcomes (4)

• Association Between Pre-Dialysis MAPSE Values and Hemodynamic Instability Within the First 60 Minutes of CVVHDF

  Within the first 60 minutes of CVVHDF initiation

• Association Between Pre-Dialysis TAPSE Values and Hemodynamic Instability Within the First 60 Minutes of CVVHDF

  Within the first 60 minutes of CVVHDF initiation

• Association Between Pre-Dialysis S' Wave Velocity (cm/s) Measured by Tissue Doppler Imaging and Hemodynamic Instability During the First 60 Minutes of CVVHDF

  Within the first 60 minutes of CVVHDF initiation

• Association Between Pre-Dialysis E/e' Ratio and Hemodynamic Instability Within the First 60 Minutes of CVVHDF

  Within the first 60 minutes of CVVHDF initiation

Study Arms (1)

CVVHDF Candidates in ICU

Adult intensive care unit (ICU) patients who are scheduled to undergo continuous veno-venous hemodiafiltration (CVVHDF). All participants will undergo transthoracic echocardiographic evaluation prior to dialysis initiation. Hemodynamic parameters will be monitored for 60 minutes following the start of CVVHDF to assess the development of hypotension or the need for vasopressor, inotropic, or fluid support.

Diagnostic Test: Transthoracic Echocardiographic Evaluation

Interventions

Transthoracic Echocardiographic Evaluation DIAGNOSTIC_TEST

Non-invasive transthoracic echocardiography will be performed prior to the initiation of continuous veno-venous hemodiafiltration (CVVHDF) in ICU patients. The evaluation includes measurements of LVOT VTI, MAPSE, TAPSE, S' wave velocity, and E/e' ratio to assess cardiac function and estimate the risk of hemodynamic instability. The procedure will be conducted at the bedside using standard parasternal and apical windows by trained intensive care physicians or cardiologists. No contrast, sedation, or invasive monitoring will be used.

CVVHDF Candidates in ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of adult patients (≥18 years) admitted to the intensive care unit (ICU) of a tertiary care hospital who are clinically indicated for continuous veno-venous hemodiafiltration (CVVHDF) due to acute kidney injury or fluid overload. All participants must have adequate transthoracic echocardiographic imaging quality prior to dialysis initiation. Only patients whose legal representatives provide informed consent will be included. Both male and female patients will be enrolled, regardless of underlying comorbidities, provided they meet the inclusion and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, Istanbul, 34303, Turkey (Türkiye)

Location

Study Officials

• Engin ihsan Turan, Specialist

  Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 13, 2025
• Study Start: June 23, 2025
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The IPD and supporting materials will be available beginning 6 months after the publication of the study results and will remain available for 1 years.
• Access Criteria: Access to data will be granted to researchers who provide a methodologically sound research proposal, approved by an independent review committee. Requests should be submitted to the principal investigator. A data-sharing agreement outlining the terms of use, data protection, and intended analyses will be required prior to data release.

Locations

TU (1)