Indian journal of anaesthesia · 2023
Norepinephrine boluses for the prevention of post-reperfusion syndrome in living donor liver transplantation: A prospective, open-label, single-arm feasibility trial.
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Emara Moataz Maher, Elsedeiq Mahmoud, Abdelkhalek Mostafa, Yassen Amr M, Elmorshedi Mohamed A
Аннотация
BACKGROUND AND AIMS: Post-reperfusion syndrome (PRS) is a serious haemodynamic event during liver transplantation (LT), which increases early graft dysfunction and mortality. This study aimed to test the efficacy and safety of norepinephrine (NE) boluses to prevent PRS during orthotopic LT.
METHODS: This feasibility phase II trial prospectively recruited a single arm of 40 patients undergoing living donor LT. The intervention was an escalated protocol of NE boluses starting at 20 µg. The primary outcome was the incidence of PRS. The secondary outcomes were arrhythmia, electrocardiographic (EKG) ischaemic changes, mean pulmonary pressure after reperfusion, 3-month survival and 1-year survival.
RESULTS: PRS occurred in 28 (70%) cases [95% confidence interval (CI) 54% to 83%, P < 0.001], with a relative risk reduction of 0.22 when compared to our previous results (90%). Twelve cases developed transient EKG ischaemic changes. All EKG ischaemic changes returned to baseline after correction of hypotension. There was no significant arrhythmia or bradycardia (95% CI 0 to 0.9). After reperfusion, the mean pulmonary artery pressure was not significantly higher than the normal limit (20 mmHg) (P = 0.88). The 3-month survival was 0.95 (95% CI 0.83 to 0.99), and the 1-year survival was 0.93 (95% CI 0.8 to 0.98).
CONCLUSION: Our findings suggest that NE boluses starting with 20 μg is feasible and effective in lowering the risk of PRS during living donor LT. Additionally, NE boluses were not associated with significant myocardial ischaemic events, arrhythmia or a rise in pulmonary pressure.
METHODS: This feasibility phase II trial prospectively recruited a single arm of 40 patients undergoing living donor LT. The intervention was an escalated protocol of NE boluses starting at 20 µg. The primary outcome was the incidence of PRS. The secondary outcomes were arrhythmia, electrocardiographic (EKG) ischaemic changes, mean pulmonary pressure after reperfusion, 3-month survival and 1-year survival.
RESULTS: PRS occurred in 28 (70%) cases [95% confidence interval (CI) 54% to 83%, P < 0.001], with a relative risk reduction of 0.22 when compared to our previous results (90%). Twelve cases developed transient EKG ischaemic changes. All EKG ischaemic changes returned to baseline after correction of hypotension. There was no significant arrhythmia or bradycardia (95% CI 0 to 0.9). After reperfusion, the mean pulmonary artery pressure was not significantly higher than the normal limit (20 mmHg) (P = 0.88). The 3-month survival was 0.95 (95% CI 0.83 to 0.99), and the 1-year survival was 0.93 (95% CI 0.8 to 0.98).
CONCLUSION: Our findings suggest that NE boluses starting with 20 μg is feasible and effective in lowering the risk of PRS during living donor LT. Additionally, NE boluses were not associated with significant myocardial ischaemic events, arrhythmia or a rise in pulmonary pressure.