NCT07202637 Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness
| NCT ID | NCT07202637 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Nord |
| Condition | Fluid Resuscitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 205 participants |
| Start Date | 2024-11-07 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 205 participants in total. It began in 2024-11-07 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Fluid administration is the first-line treatment in hypovolemic states in critically ill patients. Prediction of fluid responsiveness is possible with echocardiography by assessing the variation of the sub-aortic velocity-time integral (AoVTI) during a passive leg raising test (PLR) or Mini-fluid challenge. However, VTI-Ao measurement is not feasible in all patients due to poor echogenicity. Validation of new fluid-responsiveness indices may facilitate the evaluation in this patient population. Among the available indices, variation of the sub-pulmonary VTI is a potential criterion.
Eligibility Criteria
Inclusion Criteria: * Patient with measurable sub-pulmonary VTI in at least one of the two windows: parasternal short-axis or subcostal. * Patient with measurable sub-aortic VTI in apical 4-chamber view before and after PLR maneuver. * Patient with suspected hypovolemia or whose hemodynamic status justifies vasopressor infusion. Exclusion Criteria: * Severe left ventricular dysfunction defined by left ventricular ejection fraction (LVEF) \< 30%. * Severe right ventricular dysfunction defined by TAPSE \< 12 mm. * Cardiac arrhythmia or atrial fibrillation. * Abdominal compartment syndrome. * Amputation of one or both lower limbs. * Intracranial hypertension. * Pregnant women (ruled out by systematic pregnancy test at ICU admission). * Minors.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07202637 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fluid Resuscitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07202637 currently recruiting?
Yes, NCT07202637 is actively recruiting participants. Contact the research team at gary.duclos@ap-hm.fr for enrollment information.
Where is the NCT07202637 trial being conducted?
This trial is being conducted at Marseille 15, France, Nîmes, France.
Who is sponsoring the NCT07202637 clinical trial?
NCT07202637 is sponsored by Hospital Nord. The trial plans to enroll 205 participants.