Glycemic Control and Surgical Site Infection Incidence Among Liver Transplantation Recipients

Summary

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.

Conditions

• Liver Transplantation
• Surgical Wound Infection

Interventions

PROCEDURE

Strict Glycemic Control Group

The strict protocol adopted to conduct the study was proposed by Keegan e Cols.(2010) to be used among adult LT recipients that consist of a continuous intravenous insulin infusion. The targeted blood glucose range is 80-130 mg/dL. The procedure must be stopped when the patient can ingest at least 50% of liquid diet or receive bolus tube feedings.

PROCEDURE

Standard Glycemic Control Group

The targeted blood glucose range is 130-180 mg/dL * Blood glucose reading: ≤ 180 mg/dL - subcutaneous insulin dose: 0 * Blood glucose reading: ≥181 mg/dL and ≤250 mg/dL - subcutaneous insulin dose: 5 IU * Blood glucose reading: ≥251 mg/dL and ≤300 mg/dL - subcutaneous insulin dose: 10 IU * Blood glucose reading: ≥301 - subcutaneous insulin dose: 15 IU

Sponsors & Collaborators

• Ramon Oliveira

  lead OTHER

Principal Investigators

• Vanessa B Poveda, Ph.D

• Judith Tanner, Ph.D

• Jorge M Padilla, M.Sc

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-11

Primary Completion

2019-10-25

Completion

2020-01-15

Countries

• Brazil

Study Locations