Changes in Portal Vein Pulsatility Variability During a Tidal Volume Challenge Can Predict Fluid Tolerance

NCT ID: NCT07131228

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-11-30

Brief Summary

In critically ill patients, appropriate fluid administration is one of the cornerstones of hemodynamic management, as both hypovolemia and fluid overload can negatively impact clinical outcomes.

For years, fluid responsiveness-defined as an increase in cardiac output following volume administration-has guided decision-making in the postoperative ICU. However, fluid responsiveness alone does not guarantee fluid tolerance, which refers to the venous system's ability to accommodate volume without developing venous congestion or adverse effects such as pulmonary edema, renal or hepatic dysfunction.

The tidal volume challenge (TVC)-which consists of a transient increase in tidal volume from 6 to 8 mL/kg-has been shown to predict fluid responsiveness by enhancing the hemodynamic interaction between the heart and lungs during the cardiac cycle, as measured through dynamic arterial indices such as pulse pressure variation (PPV) or stroke volume variation (SVV). However, these indices do not provide information about fluid tolerance or the state of venous congestion.

Doppler ultrasound of the portal vein, specifically the portal pulsatility index (which under normal conditions presents as a continuous waveform due to the damping effects of the hepatic parenchyma and venous compliance), has been proposed as a non-invasive marker of systemic venous congestion. Studies have shown that an increase in the portal pulsatility index following volume loading may indicate the development of venous congestion and, therefore, poor fluid tolerance.

Since the tidal volume challenge transiently increases intrathoracic pressure and allows dynamic evaluation of cardiovascular responses, we propose that this interaction be assessed not only through arterial dynamic indices (which assess responsiveness) but also through changes in venous flow patterns-specifically, variations in portal pulsatility-so that both fluid responsiveness and tolerance can be predicted with the same test.

Conditions

Venous Congestion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Participants must meet all of the following:

Age ≥ 18 years at the time of enrollment.

Receiving controlled mechanical ventilation with a baseline tidal volume of 6 mL/kg of predicted body weight.

Clinical indication for assessment of fluid responsiveness.

Adequate acoustic window for ultrasound visualization of the portal vein.

Exclusion Criteria

Participants will be excluded if they have any of the following:

Liver cirrhosis.

Right heart failure, defined as any of the following on prior echocardiography:

Tricuspid annular plane systolic excursion (TAPSE) < 16 mm

S' wave < 10 cm/s

Right ventricular fractional area change < 35%

Left heart failure (left ventricular ejection fraction < 50%).

Intra-abdominal hypertension.

Atrial fibrillation or other significant cardiac arrhythmias.

Tricuspid regurgitation.

Poor echogenic window preventing adequate ultrasound assessment.

Presence of spontaneous breathing activity.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Negrin University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lucia Valencia

Intensive Care Unit Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

LUCIA VALENCIA, PHD

Role: CONTACT

ORI98ES@YAHOO.ES

34651010208

Other Identifiers

DrNegrinUH0000

Identifier Type: -

Identifier Source: org_study_id