Liver Transplantation Clinical Trial
Official title:
Postoperative Glycemic Control and the Surgical Site Infection Incidence Among Liver Transplantation Recipients: Randomized Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04180735 -
Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital
|
||
Completed |
NCT01011205 -
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
|
Phase 3 | |
Completed |
NCT01888432 -
Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants
|
Phase 3 | |
Recruiting |
NCT04203004 -
HOPE With Cytokine Filtration in Liver Transplantation (Cyto-HOPE)
|
N/A | |
Recruiting |
NCT04564313 -
Safety and Efficacy of Camrelizumab (Anti-PD-1 Antibody) in Recurrent HCC After Liver Transplantation
|
Phase 1 | |
Withdrawn |
NCT03596970 -
Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.
|
Phase 3 | |
Not yet recruiting |
NCT02544906 -
Propofol Versus Dexmedetomidine for Prevention of Sevoflurane Agitation in Recipients of Living Donor Liver Transplantation
|
N/A | |
Completed |
NCT03133065 -
Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs
|
Phase 4 | |
Recruiting |
NCT01705015 -
Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement
|
N/A | |
Completed |
NCT01425385 -
Autoregulation Assessment During Liver Transplantation
|
N/A | |
Completed |
NCT01655563 -
Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
|
Phase 2 | |
Terminated |
NCT01445236 -
Pilot Study of Immunosuppression Drug Weaning in Liver Recipients Exhibiting Biomarkers of High Likelihood of Tolerance
|
N/A | |
Completed |
NCT00938860 -
Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C
|
Phase 4 | |
Completed |
NCT00531921 -
Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival
|
N/A | |
Completed |
NCT00456235 -
Reduction in the Risk of Rejection by Mycophenolate Mofetil Dose Adjustment in Liver Transplant Patients With Side Effects Caused by the Calcineurine Inhibitors
|
Phase 4 | |
Terminated |
NCT00585858 -
Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant
|
N/A | |
Withdrawn |
NCT00585429 -
Evaluation of Kidney Disease in Liver Transplant Recipients
|
N/A | |
Recruiting |
NCT00147459 -
Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation
|
N/A | |
Terminated |
NCT00161356 -
Ambisome in Liver Transplant Patients
|
Phase 4 | |
Withdrawn |
NCT00167492 -
Enteric Coated Myfortic for Liver Transplant Recipients
|
Phase 4 |