Signs and symptoms of acute tacrolimus toxicity in solid organ transplant recipients: a scoping review protocol.

OBJECTIVE

The objective of the review is to chart clinical signs and symptoms presented by solid organ recipients when serum levels of tacrolimus are supratherapeutic.

INTRODUCTION

Tacrolimus is the worldwide standard immunosuppressive agent used in post-solid organ transplantation. However, this narrow-index therapeutic drug can lead to acute toxicity at supratherapeutic serum levels (≥20 ng/mL). This clinical scenario evolves dynamically, making its diagnosis and urgent treatment difficult for transplant teams, while its sequelae are potentially serious and even fatal.

ELIGIBILITY CRITERIA: Studies on solid organ recipients (heart, lung, kidney, liver) who had tacrolimus serum levels of ≥20 ng/mL and are aged ≥18 years will be considered for inclusion. There will be no limits on the care setting or geographic location. Studies on other types of transplants or studies where tacrolimus serum levels are not reported will be excluded.

METHODS

This review will follow the JBI methodology for scoping reviews, and the results will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). The following databases will be searched: MEDLINE (Ovid), Web of Science, Scielo (BIREME), LILACS (BVS), Embase (Ovid), CINAHL (EBSCOhost), Scopus, Cochrane CENTRAL, and the Cochrane Database of Systematic Reviews. Gray literature sources will also be searched. No date or language limits will be applied. Reports will be independently screened by 2 researchers. Signs and symptoms presented by patients during acute toxicity will be extracted from studies using a modified JBI data extraction tool. Data will be analyzed using descriptive statistics and the results presented in tabular and graphical formats, accompanied by narrative summaries.

REVIEW REGISTRATION: OSF osf.io/f7tzu/.