Transplant Trial Watch

Effects of pre-transplant L-carnitine supplementation on primary graft dysfunction in liver transplant recipients: a pilot, randomized, placebo-controlled clinical trial.

Khajeh, B., et al.

Research in Pharmaceutical Sciences 2019; 14(6): 504-514.


Aims
The aim of this study was to examine the impact of L-carnitine supplementation on primary graft dysfunction (PGD) and primary non-function (PNF) in liver transplant recipients.

Interventions
Patients were randomized to either the L-cartinine group or the placebo group

Participants
84 liver transplant recipients.

Outcomes
The outcomes of interest were the incidences of PGD and PNF, and 1-month patient and graft survival.

Follow-up
1 month

CET Conclusions
In this single-blinded randomised controlled trial patients awaiting liver transplant received either placebo syrup or L-carnitine 500mg/5ml syrup three times per day. The report shows no significant difference in primary non function or early allograft dysfunction. Unfortunately no power calculation had been done, so despite apparently different rates of these outcomes between the arms, there was no statistically significant difference. There was a significantly lower ALT on day 2 and ALT on day 3 with L-carnitine supplementation, but not on any of the other days in the first week after transplant. There was a significant difference in patient survival in the first month however, 97% in the L-carnitine arm and 74% in the placebo arm and the authors relate this to a longer average duration of mechanical ventilation in the placebo arm. It is not clear if this result has been skewed by one patient that required 192 days of ventilation, whereas the longest in the treatment arm was 24 days.

Jadad score
3

Data analysis
Per protocol analysis

Allocation concealment
No

Trial registration
IRCT ID: IRCT20100111003043N12

Funding source
Non-industry funded