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Postoperative glycemic control and the incidence of surgical site infection among liver transplantation recipients: randomized clinical trial

Grant number: 17/25546-7
Support type:Scholarships in Brazil - Doctorate
Effective date (Start): April 01, 2019
Effective date (End): January 31, 2020
Field of knowledge:Health Sciences - Nursing
Principal Investigator:Vanessa de Brito Poveda
Grantee:Ramon Antônio Oliveira
Home Institution: Escola de Enfermagem (EE). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

The Hyperglycemia is an important independent risk factor for the Surgical Site Infection (SSI) development among liver transplantation recipients. Objective: To evaluate the effects of an intensive postoperative protocol of blood glucose management on the surgical site infection incidence among liver transplantation recipients. Material and methods: It is an open-label clinical trial that will be randomized into 2 groups of Blood Glucose (BG) control: patients will undergo to BG control regular in the facility chosen to research development (BG targeted 130-180 mg/dL) and the second one will undergo to intensive BG control (BG targeted 80 - 130 mg/dL) until patients are eating at least 50% of a full liquid diet or receiving bolus tube feedings. A computer program will be employed to generate the randomized schedule that will be put into sequentially numbered opaque sealed envelopes by an external expert to research. A finger prick device will be used to measure the blood glucose. A blinded adjudication committee to analyse the primary endpoint SSI will adopt the SSI criteria given by the Centers for Disease Control and Prevention. The research proposal will be registered on ClinicalTrials.gov database. Central tendency and dispersion measures, Pearson's Ç2 test, Fisher's Exact Test, Mann-Whitney, Wilcoxon-Mann-Whitney and survival analysis by Kaplan-Meier estimated and Log-rank test will be used for data analyses. Expected outcomes: The results from the study should contribute to establish better clinical practices on glycemia control in the liver transplantation recipient's postoperative period aiming to reduce SSI incidence and its associated morbidity and mortality. (AU)