An observational study in Venous Congestion, sponsored by Hospital Universitario de Gran Canaria Doctor Negrín. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Hospital Universitario de Gran Canaria Doctor Negrín · Observational
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.
98 studies on the registry are indexed under Hyperemia; 44 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 46 observational studies indexed under Hyperemia.
Browse Hyperemia studies →Hospital Universitario de Gran Canaria Doctor Negrín is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This is a prospective study involving patients admitted to the intensive care unit (ICU) of a tertiary care hospital, who are under mechanical ventilation and present clinical indications for a fluid responsiveness test, such as oliguria or arterial hypotension
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 ( \< 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The absolute change in the portal pulsatility index measured in critically ill patients immediately before and after an incraese of voclumen tidal (6 to 8 ml/kg) . Measurements will be obtained using Doppler ultrasonography in vena porta.
Time frame: Measured immediately before and after the tidal volume challenge (1 minute).
To correlate changes in portal pulsatility during the test with clinical signs of fluid intolerance (e.g., acute kidney injury, pulmonary congestion).
The correlation between the change in portal pulsatility index (PPI) during the tidal volume challenge and the occurrence of clinical signs of fluid intolerance in critically ill patients. Clinical signs include acute kidney injury (as defined by KDIGO criteria), pulmonary congestion r lung ultrasound), and other hemodynamic indicators of poor fluid tolerance (proBNP).
Time frame: Assessed during the first 48 hours post-challenge.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 28 observational studies under Hyperemia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 27. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Hospital Universitario de Gran Canaria Doctor Negrín