Korean journal of anesthesiology · 2025
Bicarbonate-buffered solution versus Plasma-LyteTM in orthotopic adult liver transplantation: a pilot open-label, randomized, non-inferiority trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Yanase Fumitaka, Weinberg Laurence, Jiang Michael, Peri Varun, Caragata Rebecca, Chan Jian Wen, Miles Lachlan F, Tosif Shervin, Ellard Louise, McCall Peter, Pearce Brett, Story David A, Pillai Param, Leaver Antony, Perlman Hannah, Patel Jinesh, Eastwood Glenn, Lee Dong Kyu, Bellomo Rinaldo
Аннотация
BACKGROUND: The ideal intravenous maintenance and resuscitation fluid for patients undergoing orthotopic liver transplantation (OLT) remains unknown. We aimed to determine whether bicarbonate-buffered solution was non-inferior to Plasma-LyteTM in preventing metabolic acidosis during OLT.
METHODS: We conducted a pilot single-center, open-label, randomized trial to compare the physiological effects of intravascular volume maintenance with a bicarbonate-buffered solution vs. Plasma-LyteTM in adults undergoing OLT. Non-inferiority was defined as a median difference in the standard base excess (SBE) of less than -2.5 mEq/L. The primary endpoint was the SBE at 5 minutes post-reperfusion. Quantile regression analysis was applied to confirm non-inferiority. Secondary endpoints included other forms of acid-base and electrolyte imbalances at pre-specified time points and postoperative complications.
RESULTS: We randomized 52 adults undergoing OLT. The median (Q1, Q3) volume infused was 5 000 (3 125, 7 000) ml in the bicarbonate-buffered solution group and 5 500 (4 000, 10 500) ml in the Plasma-LyteTM group (P = 0.37). The median (Q1, Q3) SBE at 5 minutes post-reperfusion was -4.857 (-6.231, -3.565) mEq/L in patients receiving bicarbonate-buffered solution and -4.749 (-7.574, -2.963) mEq/L amongst those in the Plasma-LyteTM group. The estimated median difference by quantile regression was -0.043 mEq/L (95% CI [-1.988 to 1.902] mEq/L; one-sided P = 0.015). There were no significant differences in the acid-base secondary outcomes, number of complications, or patient mortality. There were no reported adverse events or safety concerns associated with the use of either solution.
CONCLUSIONS: A bicarbonate-buffered solution was non-inferior to Plasma-LyteTM for maintaining acid-base homeostasis post-reperfusion in OLT patients.
METHODS: We conducted a pilot single-center, open-label, randomized trial to compare the physiological effects of intravascular volume maintenance with a bicarbonate-buffered solution vs. Plasma-LyteTM in adults undergoing OLT. Non-inferiority was defined as a median difference in the standard base excess (SBE) of less than -2.5 mEq/L. The primary endpoint was the SBE at 5 minutes post-reperfusion. Quantile regression analysis was applied to confirm non-inferiority. Secondary endpoints included other forms of acid-base and electrolyte imbalances at pre-specified time points and postoperative complications.
RESULTS: We randomized 52 adults undergoing OLT. The median (Q1, Q3) volume infused was 5 000 (3 125, 7 000) ml in the bicarbonate-buffered solution group and 5 500 (4 000, 10 500) ml in the Plasma-LyteTM group (P = 0.37). The median (Q1, Q3) SBE at 5 minutes post-reperfusion was -4.857 (-6.231, -3.565) mEq/L in patients receiving bicarbonate-buffered solution and -4.749 (-7.574, -2.963) mEq/L amongst those in the Plasma-LyteTM group. The estimated median difference by quantile regression was -0.043 mEq/L (95% CI [-1.988 to 1.902] mEq/L; one-sided P = 0.015). There were no significant differences in the acid-base secondary outcomes, number of complications, or patient mortality. There were no reported adverse events or safety concerns associated with the use of either solution.
CONCLUSIONS: A bicarbonate-buffered solution was non-inferior to Plasma-LyteTM for maintaining acid-base homeostasis post-reperfusion in OLT patients.