Collapsibility Index of the Inferior Vena Cava and Kidney Transplantation

NCT06799299 | Not Yet Recruiting

• 1 other identifier: PS25002
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fluid Responsiveness in Early Post-kidney Transplantation Period

Keywords

Inferior vena cava; Fluid responsiveness; Fluid overload; Delayed graft function; Kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Inferior vena cava variability index (IVCv) and the cardiac output (to determine diagnostic performances of this index)

  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

  Day 1

Secondary Outcomes (4)

• Central venous pressure variability index and the cardiac output (to determine diagnostic performances of this index)

  Day 1

• Predictive markers of non-responsiveness to volume expansion

  Day 1

• Renal response to fluid responsiveness

  Day 30

• Intra-abdominal pressure variations

  Day 30

Study Arms (2)

Responders

cardiac output increases by \>10%.

Other: No Intervention

Non-responders

cardiac output increases by ≤10%.

Other: No Intervention

Interventions

No Intervention OTHER

No intervention

Non-responders; Responders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participation in the study will be offered to all eligible patients during the preoperative phase of renal transplantation in the nephrology intensive care unit of REIMS hospital. Eligibility will be confirmed based on clinical, biological and immunological assessments demonstrating the feasibility of the transplant. Patients will receive detailed information about the study's objectives and procedures through an information leaflet. Those who agree to participate will be included in the study. Each patient's participation will extend from Day 0 of the transplant procedure to Month 1post transplant. All patients requiring a post transplantation volume expansion will be included.

You may qualify if:

• 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.

You may not qualify if:

• Inability to obtain high-quality ultrasound images
• Unavailability of Intra-vesical pressure and central venous pressure measurements

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Edema; Delayed Graft Function

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Loïc LIEVRE

CONTACT

03 26 78 46 94; llievre@chu-reims.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

FR (1)