High versus low mean arterial pressure target in liver transplant patients. An open, controlled, single-center, randomized clinical trial - Protocol and methods (LIVER-PAM).Pedro, R. A. M., et al.
Critical Care Science 2023; 35(1): 11-18.
This protocol for a randomised controlled trial aims to investigate the effect of a higher mean arterial pressure on the incidence of renal dysfunction following liver transplantation.
Participants will be randomly assigned to either the intevention arm with the highest mean arterial pressure (MAP) of 85 - 90mmHg or the control arm with the lowest MAP of 65 - 70mmHg, for a duration of 24 hours following admission to the intensive care unit (ICU) for liver transplantation.
Adult patients (>18 years) admitted to the ICU following liver transplantation.
The primary outcome is patient death within the first 7 days. The secondary outcomes include 28-day mortality, retransplantation, renal replacement therapy, surgical site infection, days alive and free of renal dysfunction, renal dysfunction, length of stay, length of hospital stay, days alive and hospitalization-free, liver graft dysfunction, liver graft dysfunction (primary nonfunction) and major adverse kidney events.
This is the protocol for a clinical trial in liver transplantation. The study intends to examine the impact of high versus low mean arterial pressure during liver transplantation and the impact of this on renal function. The “low” MAP group (control) represents MAP 65-75mmHg and the “high” MAP group target is 85-90mmHg. Renal dysfunction will be defined by KDIGO guideline of 1.5-fold increase from baseline. Randomisation will be online and within 2 hours of entering ICU after liver transplant. The group allocation cannot be blinded, understandably. The protocol details the generic and specific management of the intervention and control groups.
ClinicalTrials.gov - NCT05068713