The effects of norepinephrine infusion combined with goal-directed fluid therapy on delayed graft function in patients undergoing kidney transplantations: study protocol for a multicenter randomized controlled trial.

BACKGROUND

Chronic kidney disease presents a formidable challenge to global healthcare systems. With ongoing advancements in surgical techniques, kidney transplantation has emerged as a principal therapeutic modality for individuals afflicted with end-stage renal disease, markedly enhancing their long-term prognosis and overall quality of life postoperatively. Nevertheless, the occurrence of delayed graft function represents a prevalent early complication following kidney transplantations, mainly stemming from the ischemia-reperfusion injury incurred by the transplanted kidneys and the utilization of extended criteria donor organs. The manifestation of delayed graft function can precipitate primary allograft nonfunction, acute rejection episodes, and potentially fatal outcomes. Vigilant attention to perioperative fluid management emerges as a cornerstone in mitigating the risk of delayed graft function. Recent strides in Goal-directed fluid therapy have garnered substantial attention within critical care contexts, with empirical evidence underscoring its favorable impact on postoperative outcomes in critically ill cohorts. However, the efficacy of Goal-directed fluid therapy specifically in the context of kidney transplantation remains a subject of ongoing debate and scrutiny. Hence, the imperative arises to investigate potential strategies aimed at attenuating the incidence of delayed graft function in this patient demographic.

METHODS

A multicenter, randomized, single-blind, two-arm parallel-group, controlled trial will be undertaken to assess the efficacy of norepinephrine in conjunction with Goal-directed fluid therapy on graft function recovery among individuals slated for kidney transplantations. Patients will be allocated randomly to either a control or intervention arm, wherein conventional fluid management or the administration of norepinephrine infusion combined with Goal-directed fluid therapy will be administered, respectively.

DISCUSSION: The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy in mitigating the occurrence of delayed graft function among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06367205. Registered on April 16, 2024.