Protective Effects of L-Carnitine Against Delayed Graft Function in Kidney Transplant Recipients: A Pilot, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.
Jafari A, Khatami M-R, et al.Journal of Renal Nutrition 2017; 27(2): 113-126.
Aims
To evaluate the possible protective effect of L-carnitine against delayed graft function (DGF) in kidney transplant recipients.
Interventions
Participants were randomized to receive either L-carnitine as a daily dose of 3-g oral syrup in three divided doses each day for four consecutive days commencing the day prior to kidney transplantation, or matching placebo.
Participants
56 patients aged >14 years undergoing their first kidney transplant from a deceased donor.
Outcomes
The primary outcome measured was the occurrence of DGF. Secondary measured outcomes were creatine clearance and the incidence of acute kidney allograft rejection episodes.
Follow-up
3 months
CET Conclusions
This pilot, double-blind, randomised controlled trial aimed to examine the protective effects of L-carnitine against delayed graft function (DGF) in 56 kidney transplant recipients of deceased donors. Randomisation was according to a computer-generated sequence using opaque sealed envelopes. Double-blinding was ensured by identical looking oral syrup of carnitine or placebo that was administered according to the same protocol. Forty-five patients completed the intervention protocol. No power calculation was reported. The modified intention to treat analysis did not find a protective effect of L-carnitine against delayed graft function and showed no differences for length of hospital stay or acute rejection episodes during hospitalisation. The study used neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker of proximal renal tubular injury but found no differences in plasma NGAL levels between groups.
Data analysis
Modified intention-to-treat analysis
Trial registration
Iranian Registry of Clinical Trials - IRCT 201312233043N9