Centre Hospitalier Nord, HCL
Lyon, France, 69004
NCT Number: NCT06712537
Liver transplantation in France represents a currently significant transplantation activity with a steady increase in the number of transplanted patients, with 1,294 liver transplants according to the Biomedicine Agency in 2022 compared to 806 liver transplants in 2000. 4% of these transplanted patients, or 54, underwent combined liver-kidney transplantation in 2022.
The indication for combined transplantation fits within several scenarios: patients indicated for liver transplantation with severe renal insufficiency as a comorbidity, which worsens the prognosis in the case of liver transplantation alone; patients with renal insufficiency indicated for kidney transplantation with decompensated liver disease as a comorbidity; and diseases affecting both organs in a combined and severe manner.
However, some American studies have highlighted the significant prevalence of kidney transplant failure during simultaneous liver-kidney transplantation, estimated at around 20% at 3 months post-transplant. This failure of renal function recovery after the double transplant is defined by the need for dialysis or the occurrence of death. This represents a major issue concerning the mortality and morbidity of patients who have undergone simultaneous liver-kidney transplantation.
The aim of this study is to identify the risk factors for failure of renal function recovery after combined liver-kidney transplantation, thus indicating the futility of the kidney transplant in this context of double transplantation.
The outcomes will be multiple. On one hand, we will identify the population most suitable to benefit from this intervention, which will improve recommendations on access to simultaneous liver-kidney transplantation. On the other hand, we will develop an optimized strategy for the use of available grafts, in order to better address the current organ shortage and the increasing number of patients waiting for transplants.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Lyon, France, 69004
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Time frame: The outcome is collected at 3 months following the simultaneous liver-kidney transplantation.
The primary outcome is met if the patient undergoes dialysis (continuous or intermittent) or is dead at 3 months after simultaneous liver-kidney transplantation. The outcome is not met if the patient required dialysis during the early stages of their transplant but no longer needs it and is not undergoing dialysis at 3 months. The criterion is not met if the patient dies after the 3-month period following simultaneous liver-kidney transplantation.
This outcome is collected from electronic medical records by designated and authorized personnel. These records are stored within the hospital departments where patients are being monitored.
Hospices Civils de Lyon
Other
Renal Futility Following Simultaneous Liver-Kidney Transplantation: What Identified Risk Factors to Avoid It?
Acronym: FUTILITY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.