- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03474666
Glycemic Control and Surgical Site Infection Incidence Among Liver Transplantation Recipients
Postoperative Glycemic Control and the Surgical Site Infection Incidence Among Liver Transplantation Recipients: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Surgical Site Infections (SSI's) are the most frequent healthcare-associated infections and are an important infectious complication in the postoperative period among liver transplantation (LT) recipients. SSI incidence among LT recipients, whose allografts were from deceased donors, varied from 9.6% to 35.5% according to a recent literature review. In general surgical procedures, SSI increases the length of stay, morbidity and healthcare costs. Besides that, among LT recipients SSI can raise the risks of the allografts dysfunctions, acute rejections and as a consequence a reduction in the recipient's survival.
There are several risk factors for SSI among LT recipients. There is a relationship among supply sterilization quality, the characteristics of surgical procedure, the operation room environment as well as the allograft's and recipient's conditions and SSI occurrence. In regard to LT recipients, results from previous research highlighted hyperglycemia as an important independent predictor of SSI. Furthermore, regarding this population, it is known from observational studies that LT recipients affected by hyperglycemia are exposed, approximately, to three times the risk of SSI comparatively to LT recipients not exposed.
The concern about maintaining normoglycaemia in acute care facilities is not recent; several studies have been done including on clinical and surgical patients from some medical specialities showing the morbidity and mortality reduction throughout the adoption of strict glycaemic control protocols.
However, among critical surgical patients the LT recipients are highlighted; since they are exposed to impairment in blood glucose metabolism in the perioperative period as a consequence of an intraoperative acute stress state, blood loss and transfusions, the reperfusion phase, use of glucocorticoids and catecholamines.
Results from previous studies pointed the hyperglycaemia among LT recipient as a frequent complication, 94% of them presented it at least once in the transplantation's postoperative period.
The high blood glucose levels can produce electrolyte and acid-base disturbances besides altered plasmatic distribution of sodium. There are impairments to the white blood cells activities, such as reduction in the adherence, chemotaxis, phagocytosis and superoxide formation. Lymphocytes apoptosis combined with T-cell activities suppression besides attenuation of immunoglobulin's work as a consequence of glycosylation.
In spite of evidence from laboratory studies that indicate remarkable impairments caused by hyperglycemia in immune model animals immunologic system, uncertainties remain to evaluate the glycaemic control as a strategy for SSI prevention. Analysing the guidelines to prevent SSI published by World Health Organization, Centers for Disease Control and Prevention (United States of America), National Institute for Health and Care Excellence (United Kingdom), Society for Healthcare Epidemiology of America (United States of America) and Brazilian Health Regulatory Agency conditional recommendation regard the adoption of strategies to strict glycaemic control in the postoperative phase, besides there is no consensus about how glycaemic level could work as a protective factor for SSI among patients who underwent general surgeries.
Moreover, there have been few investigations evaluating the hyperglycaemia effects or blood glucose control in the postoperative phase of LT recipients. Besides the few studies concerned on the topic among LT recipients, the majority of them were observational studies, designed as retrospective cohorts, which could compromise the body's evidence quality. Also, in the previous studies enrolled patients underwent liver-kidney transplantation, which can cause a negative impact on the effects of glycemic control analyses and there is research where recipients presented lower means of Model for End-Stage Liver Disease (MELD) from 19.0 to 28.2 that are lower MELD means than the observed in Brazilian transplantation centres. Finally, we observed the absence of clear criteria for SSI diagnosis in some studies.
It is known that the preoperative screening in living donor LT of donors and recipients as baseline characteristics are different of LT whose allografts came from deceased donors; for instance, liver-kidney recipients who undergo to distinct immunosuppression schemes. Furthermore, lower MELD scores represent LT recipients that could be exposed to diverse risk factors for SSI when compared to LT recipients who the MELD score is higher.
Thus, it sounds appropriate that research aiming to evaluate the effect of strict blood glucose control on SSI incidence among LT recipients should be made. In addition, nurse-initiated blood glucose control protocols, among critically ill patients, are frequently developed. And, a recent literature review pointed to the lack of prospective studies that addressed the evaluation of the outcomes of strict glycaemic control among LT recipients on SSI incidence.
The study hypothesis is: the postoperative strict glycaemic control reduces the SSI incidence among LT recipients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
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São José Dos Campos, São Paulo, Brazil, 12210110
- Hospital Santa Casa de São José dos Campos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Strict Glycemic Control Group
Intravenous insulin as described by Keegan and Cols.
2010.
|
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.
|
Active Comparator: Standard Glycemic Control Group
Subcutaneous insulin as instititional protocol.
|
The targeted blood glucose range is 130-180 mg/dL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical Site Infection
Time Frame: SSI occurs within 30 days after the LT
|
Surgical site infection following the Centers for Disease Control and Prevention defining criteria (2018)
|
SSI occurs within 30 days after the LT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hyperglycemia
Time Frame: During first 48h ICU stay
|
Hyperglycemia > 250 mg/dL
|
During first 48h ICU stay
|
Hypoglycemia
Time Frame: During first 48h ICU stay
|
Hypoglycemia < 60 mg/dL
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During first 48h ICU stay
|
Duration of mechanical ventilation
Time Frame: Within 30 days after LT
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Duration of mechanical ventilation through postoperative ICU stay
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Within 30 days after LT
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ICU stay
Time Frame: Within 30 days after LT
|
ICU stay until 30 days after LT
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Within 30 days after LT
|
Ward stay
Time Frame: Within 30 days after LT
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Postoperative ward stay
|
Within 30 days after LT
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Death
Time Frame: 90 days after LT
|
Death within 90 days after LT
|
90 days after LT
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Surgical Site Infection or death
Time Frame: Surgical site infection within 20 days following liver transplantation or death within 90 days following liver transplantation
|
Surgical site infection following the Centers for Disease Control and Prevention defining criteria (2018)
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Surgical site infection within 20 days following liver transplantation or death within 90 days following liver transplantation
|
Hospital length of stay
Time Frame: Until 100 weeks after liver transplantation
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Time between the hospital admission to liver transplantation and hospital discharge
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Until 100 weeks after liver transplantation
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PPI preoperative use and SSI
Time Frame: Preoperative period
|
Proton-pump inhibitor and ocurrence of SSI
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Preoperative period
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Vanessa B Poveda, Ph.D
- Study Director: Judith Tanner, Ph.D
- Study Director: Jorge M Padilla, M.Sc
Publications and helpful links
Helpful 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 80351717.7.0000.5392
- U1111-1210-2322 (Other Identifier: Universal Trial Number - World Health Organization)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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