Glycemic Control and Surgical Site Infection Incidence Among Liver Transplantation Recipients

NCT03474666 | Terminated

• 2 other identifiers: 80351717.7.0000.5392U1111-1210-2322
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Liver Transplantation; Surgical Wound Infection; Hiperglycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Hyperglycemia

  During first 48h ICU stay

• Hypoglycemia

  During first 48h ICU stay

• Duration of mechanical ventilation

  Within 30 days after LT

• ICU stay

  Within 30 days after LT

• Ward stay

  Within 30 days after LT

Other Outcomes (1)

• PPI preoperative use and SSI

  Preoperative period

Study Arms (2)

Strict Glycemic Control Group

ACTIVE COMPARATOR

Intravenous insulin as described by Keegan and Cols. 2010.

Procedure: Strict Glycemic Control Group

Standard Glycemic Control Group

ACTIVE COMPARATOR

Subcutaneous insulin as instititional protocol.

Procedure: Standard Glycemic Control Group

Interventions

Strict Glycemic Control Group PROCEDURE

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.

Strict Glycemic Control Group

Standard Glycemic Control Group PROCEDURE

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

Standard Glycemic Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramon Oliveira: lead

Study Sites (1)

Hospital Santa Casa de São José dos Campos

São José dos Campos, São Paulo, 12210110, Brazil

Location

Related Publications (1)

• Oliveira RA, Tanner J, Mancero JMP, de Brito Poveda V. Effects of Intensive Blood Glucose Control on Surgical Site Infection for Liver Transplant Recipients: A Randomized Controlled Trial. Transplant Proc. 2023 Jan-Feb;55(1):170-177. doi: 10.1016/j.transproceed.2022.10.062. Epub 2022 Dec 24.

  PMID: 36567173 DERIVED

Related Links

• Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017
• Effect of antibiotic prophylaxis on the risk of surgical site infection in orthotopic liver transplant
• The effect of surgical site infections on outcomes and resource utilization after liver transplantation
• Risk factors for development of surgical site infections among liver transplantation recipients: An integrative literature review
• Bacteremia and septic shock after solid-organ transplantation.
• The direct and indirect effects of infection in liver transplantation: pathogenesis, impact, and clinical management.
• Causes of mortality after liver transplantation: a single center experience in mainland china.
• Safety and effectiveness of intensive insulin protocol use in post-operative liver transplant recipients.

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vanessa B Poveda, Ph.D

  STUDY CHAIR

• Judith Tanner, Ph.D

  STUDY DIRECTOR

• Jorge M Padilla, M.Sc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D Candidate at University of Sao Paulo School of Nursing

Model Details: Insulin initially as continuous infusion/subcutaneous for first 24-48 hours followed by subcutaneous administration once subjects eating until hospital discharge.

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 22, 2018
• Study Start: March 11, 2018
• Primary Completion: October 25, 2019
• Study Completion: January 15, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)