NCT07304661

Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness

Not yet recruiting Last updated 26 December 2025

What this trial tests

trial in Hemodynamic Instability in 48 participants. Not yet recruiting.

Timeline

1 January 2026

Primary endpoint
1 January 2027

1 June 2027

Quick facts

Lead sponsor	Izmir Katip Celebi University
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	48
Start date	1 January 2026
Primary completion	1 January 2027
Estimated completion	1 June 2027
Sites	1 location across Turkey (Türkiye)

Conditions studied

• Hemodynamic Instability — all drugs for Hemodynamic Instability →
• Hypovolemia — all drugs for Hypovolemia →
• Critical Illness — all drugs for Critical Illness →
• Pulse Pressure Variation — all drugs for Pulse Pressure Variation →

Sponsor

Izmir Katip Celebi University

Who can join

18 and older, any sex, with Hemodynamic Instability or Hypovolemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hemodynamic instability remains one of the leading causes of morbidity and mortality among critically ill patients in intensive care units. One major contributor to this instability is intravascular fluid deficit. Although fluid administration is often preferred as an initial intervention, inaccurate estimation of fluid requirements carries significant risks. Inadequate resuscitation may lead to tissue hypoperfusion and organ dysfunction, whereas excessive fluid loading is associated with pulmonary edema, increased intra-abdominal pressure, multi-organ dysfunction, and increased mortality. Consequently, reliable prediction of fluid responsiveness is considered a critical determinant in modern intensive care management.

The limited reliability of static parameters in predicting fluid responsiveness and the fact that PPV retains its validity only under specific clinical conditions highlight the need for more effective methods. In recent years, hemodynamic changes assessed during the passive leg raising (PLR) maneuver have gained prominence; particularly, left ventricular outflow tract velocity time integral (LVOT VTI)-based cardiac output measurements have been identified as a strong parameter for predicting fluid responsiveness . Moreover, changes in pulse pressure variation (PPV) during PLR have also been reported as a potential predictor; however, the number of studies prospectively comparing PPV variation and LVOT VTI-based cardiac output change within the same patient population remains limited . Therefore, the proposed study aims to fill this gap in the literature and contribute to fluid management in the intensive care setting.

The aim of this study is to compare the performance of PPV variation and LVOT VTI-based cardiac output change after the PLR maneuver in predicting fluid responsiveness among mechanically ventilated critically ill patients, and to determine the diagnostic value of both methods. The findings of the present study are expected to support more reliable decision-making in fluid therapy and provide clinical evidence toward the individualization of fluid management in intensive care practice.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.