The addition of simvastatin portal venous infusion to cold storage solution of explanted whole liver grafts for facing ischemia/reperfusion injury in an area with low rate of deceased donation

Conditions

Liver transplantation Surgery

Duilio Pagano, Davide Cintorino, Sergio Li Petri, Calogero Ricotta, Pasquale Bonsignore et al. (7 authors)

Journal of the American College of Surgeons2022-10-14

10.1097/01.xcs.0000896440.30606.34

The addition of simvastatin administration to cold storage solution of explanted whole liver grafts for facing ischemia/reperfusion injury in an area with a low rate of deceased donation: a monocentric randomized controlled double-blinded phase 2 study.

Pagano D, Oliva E, Khouzam S, Tuzzolino F, Cintorino D, Li Petri S, di Francesco F, Ricotta C, Bonsignore P, Tropea A, Calamia S, Costanzo F, Luca A, Gruttadauria S.

2018-12-276 citations

10.1186/s12893-018-0455-7

Interventions

Current interventions as of 09/02/2018: Patients will be randomized in a 1:1 ratio to receive an organ perfused or not perfused with a single dose of simvastatin immediately before the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patient on waiting-list for liver transplantation from deceased donors at Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

Exclusion criteria

Exclusion criteria: 1. Recipients with acute liver disease 2. Pediatric patients or pediatric donors 3. Patients undergoing re-LT 4. Patients undergoing split or living donor LT

Design outcomes

Primary

Measure	Time frame
Graft survival	—

Secondary

Measure	Time frame
1. Patient survival 2. The incidence of primary no function (PNF) 3. Differences in transaminases, INR and bilirubin values on POD 2, 7, 15, 30, 90, 180, 270, 360, 540 4. Lengths of hospital stays and intensive care unit stays 5. Clavien classification will be used to evaluate postoperative events in the first 6 months after transplantation (surgical and medical complications, including infections) 6. 1-year patient and graft-rejection-free survival	—

Measure

Time frame

1. Patient survival 2. The incidence of primary no function (PNF) 3. Differences in transaminases, INR and bilirubin values on POD 2, 7, 15, 30, 90, 180, 270, 360, 540 4. Lengths of hospital stays and intensive care unit stays 5. Clavien classification will be used to evaluate postoperative events in the first 6 months after transplantation (surgical and medical complications, including infections) 6. 1-year patient and graft-rejection-free survival

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Countries

Italy

Outcome results

None listed