Celsior versus University of Wisconsin preserving solutions for liver transplantation

INTERVENTION: 1. Celsior preservation solution (experimental): N = 51 adult transplant recipients. Donor liver recovery was performed using conventional multi‐organ procurement techniques. Celsior preservation solution cooled to 4°C was perfused by gravity through the aorta (4 L) and portal vein (2 L) in situ and on the back table through the portal vein (1 L). After recovery, the grafts were kept at 4ºC in conventional bags containing Celsior solution until transplantation. The liver transplant was performed preserving the retrohepatic vena cava (piggyback technique) without venovenous bypass. Before reperfusion, the graft was washed through the portal vein with 1200 ml cold Ringer's lactate. Reperfusion of the grafted liver was followed by hepatic arterial and biliary reconstruction. Total duration of follow‐up: five years. 2. University of Wisconsin preservation solution (active comparator): N = 51 adult transplant recipients. Donor liver recovery was performed using conventional multi‐organ procurement techniques. University of Wisconsin preservation solution cooled to 4°C was perfused by gravity through the aorta (3 L) and portal vein (2 L) in situ and on the back table through the portal vein (1 L). After recovery, the grafts were kept at 4ºC in conventional bags containing University of Wisconsin solution until transplantation. The liver transplant was performed preserving the retrohepatic vena cava (piggyback technique) without venovenous bypass. Before reperfusion, the graft was washed through the portal vein with 1200 ml cold Ringer's lactate. Reperfusion of the grafted liver was followed by hepatic arterial and biliary reconstruction. Total duration of follow‐up: five years. CONDITION: Liver transplantation ; Surgery ; Surgical operation and other surgical procedures PRIMARY OUTCOME: 1. Intra‐operative mortality. Time Frame: intervention day.; 2. Post‐reperfusion syndrome. Time Frame: Intervention day. Post‐reperfusion syndrome was defined as a decrease in the mean arterial pressure of more than 30% of the baseline value for more than one minute during the first five minutes after graft reperfusion. In relation to post‐reperfusion syndrome, 17 intra‐operatory variables were analysed, eight haemodynamic and nine metabolic. These variables were heart rate, mean arterial blood pressure, central venous pressure, mean pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac output, systemic vascular resistance index, pulmonary vascular resistance index, central body temperature, arterial pH, standard bicarbonate, base excess, serum sodium, serum potassium, ionised calcium, magnesaemia, and glycaemia.; 3. Primary non‐function or primary dysfunction graft. Time Frame: first week post‐liver transplantation. Primary non‐function defined as the acute failure of the transplanted liver, leading to re‐transplantation or death within seven days of the initial procedure, with no identifiable cause of graft failure. Primary dysfunction was defined as the elevation of transaminases 30‐fold above normal and a prothrombin time greater than 20 seconds maintained for 3 days in the first week post‐LT; 4. Mortality during the first 30 days post‐liver transplantation. Time Frame: 30 days post‐liver transplantation.; 5. Liver re‐transplantation and causes. Time Frame: Five years post‐liver transplantation.; 6. Graft and patient survival during the follow‐up period. Time Frame: 5 years post‐liver transplantation. INCLUSION CRITERIA: 1. Adult liver transplant recipients 2. Minimum age: 18 years, maximum age: 70 years 3. Both sexes SECONDARY OUTCOME: 1. Days in the Intense Care Unit. Time Frame: first 15 days post‐liver transplantation.; 2. Rates of acute rejection. Time Frame: Five years post‐liver transplantation. Acute cellular rejection was proven by percutaneous liver biopsy.; 3. Rates of chronic rejection. Time Frame: Five years post‐liver transplantation. Chronic rejection was proven by percutaneous liver biopsy.; 4. Infectious complications. Time Frame: Five years post‐liver transplantation.; 5. Vascular and biliary complications. Time Frame: Five years post‐liver transplantation.; 6. Values of aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma‐glutamyltransferase (GGT), bilirubin, and prothrombin activity. Time Frame: first 5 days post‐liver transplantation.