Transplant Trial Watch

Glycemic Control Reduces Infections in Post-Liver Transplant Patients: Results of a Prospective, Randomized Study.

Wallia A, Schmidt K, et al.

The Journal of Clinical Endocrinology & Metabolism 2016 [record in progress]


Aims
To determine whether intensive glucose management in the inpatient setting improves outcomes in post liver transplant recipients.

Interventions
Participants were randomized to receive either intensive glycemic control (140 mg/dl), versus moderate glycemic control (180 mg/dl).

Participants
164 patients undergoing liver transplantation aged 18 – 80 years.

Outcomes
The primary outcome measured was the number of patients experiencing an episode of rejection within the first year, and the secondary outcome included the number of patients experiencing an infection also within the first year . Other outcomes measured were glucose levels, Hemoglobin A1c, rejection episodes, need for acute anti-rejection treatment, infections, rehospitalizations, graft survival and death.

Follow-up
1 year

CET Conclusions
This study investigated the impact of glycaemic control on post-liver-transplant rejection and infection rates. It was powered to assess acute rejection in the first year as the primary outcome and did not find a significant difference comparing the two target ranges of blood glucose monitoring (20% versus 24%). There was however a significant decrease in post-operative infections with the tighter glucose control regimen (42% versus 66%). Significantly there was a higher risk of hypoglycaemia (<7.0mmol/L) in the group with the lower target blood glucose (33% versus 12%). The study was randomised via a computer-generated system, and no blinding scheme is described, although it may have proved impractical to implement. The study had full follow up, with no dropouts and no cross-overs between the trial arms. Once the patients were discharged it is not clear what glucose monitoring regimen they followed, and their HbA1c results are not presented.

Jadad score
3

Data analysis
Available case analysis

Allocation concealment
No

Trial registration
Clinical Trials.gov - NCT01211730

Funding source
Not reported