Perioperative Prostaglandin E1 Infusion In Live Donor Liver Transplantation: A Double Blind Placebo Controlled Randomized Trial.
Bharathan VK, Chandran B, et al.Liver Transplantation 2016;22(8):1067-74
Aims
To evaluate the role of perioperative Prostaglandin E1 (PGE1) infusion in Live Donor Liver Transplantation (LDLT).
Interventions
Participants were randomized to receive either perioperative PGE1 infusion (500mcg PGE1 to 50ml of Normal Saline), or placebo (50ml Normal Saline alone).
Participants
100 patients undergoing LDLT aged > 18 years of age.
Outcomes
The primary outcome measured was early allograft dysfunction. Secondary outcomes measured included levels of bilirubin, creatinine, international normalised ratio, aspartate aminotransferase, alanine aminotransferase, hepatic artery thrombosis, primary non function, acute kidney injury, postoperative bleeding, post-transplant hospital stay and hospital mortality.
Follow-up
End of hospital stay
CET Conclusions
This double blind RCT from India randomised live donor liver transplant recipients to perioperative prostaglandin E1 (PGE1) infusion or placebo. PGE1 infusion led to a reduction in the risk of acute kidney injury and improvements in peak ALT levels. Other liver parameters, including the primary endpoint of reduction in early allograft dysfunction, did not reach statistical significance. No increase in adverse effects were reported. The authors conclude that PGE1 infusion should be routine practice in this patient population. The methodology of this trial is reasonably robust, with use of a saline placebo and blinding of patients, surgeons and anaesthetists. Per-protocol, rather than intent-to-treat analysis is employed. Perhaps the biggest issue is a lack of statistical power. The authors based their power calculation on a large reduction in EAD from 36% to 12%. A potentially clinically-significant reduction to 22.4% was observed, along with reductions in other liver function parameters and a reduction in mortality from 20% to 10.1%. None of these outcomes reached statistical significance, making conclusions on liver transplant outcome difficult to draw.
Data analysis
Modified intention-to-treat analysis
Trial registration
Clinical Trials Registry of India - CTRI/2013/13/09/003991