Effects of intensive blood glucose control on surgical site infection for liver transplant recipients: A Randomized Controlled Trial

Author(s)

Ramon Antônio Oliveira

• Document type: Doctoral Thesis
• Press: São Paulo.
• Institution: Universidade de São Paulo (USP). Escola de Enfermagem (EE/SBD)
• Defense date: 2020-12-14

Examining board members

Vanessa de Brito Poveda; Ricardo de Souza Cavalcante; Bartira de Aguiar Roza; Judith Tanner

• Advisor: Vanessa de Brito Poveda

Abstract

Background: The evidence supporting intensive blood glucose control to prevent surgical site infections (SSIs) among liver transplant recipients is insufficient. Aim: To assess the effects of postoperative intensive blood glucose control protocol (IBGC) against standard blood glucose control (SBGC) on the incidence of SSI among adult liver transplant recipients. Methods: This is a parallel-design, randomized controlled trial, comparing two blood glucose control protocol beginning at the time of the post-operative admission of the recipient to the Intensive Care Unit. All recipients who consented to take part in this trial were randomly assigned to either group, IBGC (blood glucose targeted on 80-130 mg/dL) or SBGC (130-180 mg/dL). The primary outcome, SSI was assessed at 30 days by a blind adjudication panel. This trial was approved by the relevant ethics committee before the study initiation and enrolment. Analysis was based on intention-to-treat information. Categorical variables were analysed by Pearson\'s chi-squared test or Fisher\'s exact test, as appropriate. Normality was tested using the Kolmogorov-Smirnov test. Continuous variables were analysed by the Student t test for normally distributed data and the Mann-Whitney test for all other data. The comparison between glycaemic levels was calculated using analysis of variance of repeated measures (ANOVA). To keep the level of global significance the Bonferroni correction was used. Statistical significance was set at P= 0.05. The ClinicalTrials.gov identifier is NCT03474666. Results: Of the 41 liver transplant recipients enrolled onto the trial, 20 were randomly allocated to the IBGC group and 21 to the SBGC group. There were no significant differences in SSIs among recipients allocated to either group (RR 0,78, 95% CI 0.21-2.88; P=0.695). Mean blood glucose levels were significantly lower in the IBCG group in the 24-hour period after surgery (145.0 ± 20.7 mg/dL and 230.2 ± 51.6 mg/dL; P=0.001). While there were fewer episodes of hypoglycaemia in the IBGC group, this did not reach statistical significance. There were no episodes of severe hypoglycaemia in either group. Hyperglycaemia and severe hyperglycaemia were significantly more frequent in the SBGC group (RR 0.70, 95% CI 0.52-0.93; P=0.009 and RR 0.07; 95% CI 0.01-0.48; P< 0.001, respectively). The length of mechanic ventilation was similar between the two groups (IBGC 19.6 ± 14.7 h vs 16.2 ± 11.3 h; P=0.884). A tendency of shorter length of ICU stay was detected on the IBGC (8.0 [4.0-13.5 days]) comparatively to the SBGC (11.0 [7.0-15.0 days]) (P=0.097). Length of hospital stay was significantly shorter for recipients in the IBGC group (13.1 ± 5.5 vs 19.3 ± 12.1 days; P=0.043). The occurrence of death was similar between recipients allocated to the IBGC and SBGC (20.0% vs. 14.3%; P=0.697). The risk of death was higher among recipients who developed deep incisional or organ/space SSI comparatively to those who did not (RR 4.95; CI 95% 1.54- 15.86; P=0.007). Conclusion: Although this small trial did not find intensive blood glucose control reduced SSI, it was associated with lower blood glucose levels, fewer episodes of hyperglycaemia and severe hyperglycaemia, and shorter length of hospital stay. Also, this trial was carried out in a single transplant centre in a middle-income country. It would be interesting to see if the results were supported by a multicentre trial. (AU)

• FAPESP's process: 17/25546-7 - Postoperative glycemic control and the incidence of surgical site infection among liver transplantation recipients: randomized clinical trial
• Grantee: Ramon Antônio Oliveira
• Support Opportunities: Scholarships in Brazil - Doctorate