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Starting soon Observational

Collapsibility Index of the Inferior Vena Cava and Kidney Transplantation

NCT06799299 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-02-01
Last updated
2025-01-29

Condition(s) studied

Fluid Responsiveness in Early Post-kidney Transplantation Period

Investigational drug(s) / intervention(s)

No Intervention

No Intervention: No intervention

Study summary

Delayed graft function following renal transplantation is common occurrence and is associated with an increased risk of acute rejection and chronic allograft nephropathy. Post transplant patients are usually hyperhydrated to optimize renal blood flow and thus graft function. However, cardiac failure to respond adequately to volume expansion can lead to renal venous congestion and visceral interstitial sodium and water overload, both of which are associated with the delayed kidney graft function. To our knowledge, no predictive index for fluid responsiveness has been evaluated in post-renal transplantation setting. In intensive care, the inferior vena cava variability index measured by transthoracic echocardiography (TTE) under standardized breathing conditions, is a simple, non-invasive and effective tool for predicting fluid responsiveness in patients hospitalized for sepsis. Applying this index in the post-renal transplantation period could potentially optimize early management and enhance the recovery of kidney graft function.

In this study, we aim to evaluate the diagnostic performance of the inferior vena cava variability index in predicting fluid responsiveness after renal transplantation. This is a monocentric, prospective, and observational study conducted in the nephrology intensive care unit at University Reims Hospital.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * Diagnosis of End-stage renal disease (ESRD) * Hospitalization in the nephrology intensive care unit at Reims University Hospital * Hospitalization due to renal transplantation * Willingness to provide informed consent and participate in the study * Receiving volume expansion following renal transplantation. Exclusion criteria: * Inability to obtain high-quality ultrasound images * Unavailability of Intra-vesical pressure and central venous pressure measurements

Primary outcome measure(s)

  • Inferior vena cava variability index (IVCv) and the cardiac output (to determine diagnostic performances of this index) — Day 1
    IVCv will be measured by echocardiography before the volume expansion Patients will be classified as responders if their cardiac output increases by \> 10% after volume expansion, and in non-responders if not

Trial sites (1)

FacilityCityRegionStatus
Damien JOLLY Reims France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06799299 on ClinicalTrials.gov ↗ ← All trials in France