Liver Transplantation Clinical Trial
Official title:
Postoperative Glycemic Control and the Surgical Site Infection Incidence Among Liver Transplantation Recipients: Randomized Clinical Trial
Verified date | March 2020 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Context: 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 BG control regular in the facility chosen to research development (BG targeted 130-180 mg/dL) and the second one will undergo 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 χ2 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 of the study should contribute to establishing better clinical practices on glycemic control in the liver transplantation recipient's postoperative period aiming to reduce SSI incidence and its associated morbidity and mortality.
Status | Terminated |
Enrollment | 41 |
Est. completion date | January 15, 2020 |
Est. primary completion date | October 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Recipients of LT whose allograft came from deceased donors - Able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious. - Blood glucose level over 130 mg/dL in the first 24 hours postoperatively Exclusion Criteria: - The patients that underwent any kind of surgery with or without prosthesis implant in the 30 days before the LT - Recipients submitted to multiple organ transplantation |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Santa Casa de São José dos Campos | São José Dos Campos | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Ramon Oliveira |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | PPI preoperative use and SSI | Proton-pump inhibitor and ocurrence of SSI | Preoperative period | |
Primary | Surgical Site Infection | Surgical site infection following the Centers for Disease Control and Prevention defining criteria (2018) | SSI occurs within 30 days after the LT | |
Secondary | Hyperglycemia | Hyperglycemia > 250 mg/dL | During first 48h ICU stay | |
Secondary | Hypoglycemia | Hypoglycemia < 60 mg/dL | During first 48h ICU stay | |
Secondary | Duration of mechanical ventilation | Duration of mechanical ventilation through postoperative ICU stay | Within 30 days after LT | |
Secondary | ICU stay | ICU stay until 30 days after LT | Within 30 days after LT | |
Secondary | Ward stay | Postoperative ward stay | Within 30 days after LT | |
Secondary | Death | Death within 90 days after LT | 90 days after LT | |
Secondary | Surgical Site Infection or death | Surgical site infection following the Centers for Disease Control and Prevention defining criteria (2018) | Surgical site infection within 20 days following liver transplantation or death within 90 days following liver transplantation | |
Secondary | Hospital length of stay | Time between the hospital admission to liver transplantation and hospital discharge | Until 100 weeks after liver transplantation |
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