Liver transplantation remains the only cure for patients with end-stage liver disease. Despite continuous advances in medical care, ischemia-reperfusion injury (IRI) (tissue damage that occurs when blood supply is restored to an area that has been deprived of oxygen) remains a major contributor to complications with the newly transplanted liver. IRI can lead to a condition known as post-reperfusion syndrome that involves profound narrowing of blood vessels, significantly low blood pressure, and an increased requirement of medication to control blood pressure. In some cases, post-reperfusion syndrome can progress to a condition known as post-reperfusion vasoplegia which is a condition where severely low blood pressure persists even after blood flow is restored to the liver. This is often accompanied by complications such as improperly functioning kidneys, blood clotting disorders, and complications with the transplanted liver that can significantly affect patient outcomes. Recent studies have shown than inhaled nitric oxide (a gas that can relax blood vessels) can reduce the severity of IRI in the liver. This study is being conducted to determine whether the administration of inhaled nitric oxide during surgery reduces the severity of post-reperfusion syndrome and the incidence of post-reperfusion vasoplegia in adult patients undergoing liver transplantation. This is a before-and-after study design that will involve both the retrospective collection of data between the time period of January 1, 2020 - May 31, 2025 and prospective interventions involving adult liver transplant recipients.
Adult patients (age ≥ 18 years)
Undergoing or underwent (for the retrospective "before" group) primary orthotopic liver transplantation. Retrospective data collection for retrospective group will take place between January 1, 2020 - May 31, 2025.
Written informed consent obtained for patients in the prospective ("after") group
History of pulmonary arterial hypertension (mean pulmonary artery pressure ≥ 25 mmHg)
Re-transplantation
Acute fulminant hepatitis
Combined organ transplantation (e.g., liver-kidney)
Parallel
Prospective iNO Administration ("After" Group)
DrugAdult patients undergoing liver transplantation after the implementation of the iNO protocol, with prospective intervention involving intraoperative administration of iNO and prospective data collection. Inhaled nitric oxide will be administered via the anesthesia machine, under the supervision of the attending Anesthesiologist, at a concentration of 20 parts per million (ppm) starting at induction of anesthesia. At the onset of the anhepatic phase (i.e., after explantation of the native liver), the concentration will be increased to 80 ppm. Administration will be continued until the end of the surgical procedure, at which point iNO will be discontinued.
No Intervention Retrospective "Before" Group
Other interventionAdult liver transplant recipients identified retrospectively from the institutional transplant database, including all patients who underwent orthotopic liver transplantation since the implementation of the OneChart electronic medical record (EMR) system between the time period of January 1, 2020 - May 31, 2025.
Impact of nitric oxide to reduce the severity of post-reperfusion syndrome in adult patients undergoing liver transplantation
This will be measured by considering the following parameters for these indications following iNO administration: • Incidence of post-reperfusion syndrome, defined as a ≥30% drop in mean arterial pressure within 5 minutes of reperfusion, lasting for more than 1 minute
Impact of nitric oxide to reduce the incidence of incidence of post-reperfusion vasoplegia in adult patients undergoing liver transplantation
This will be measured by considering the following parameters for these indications following iNO administration: • Incidence of vasoplegia, defined as persistent hypotension requiring norepinephrine ≥ 0.1 µg/kg/min for ≥ 30 minutes despite adequate volume resuscitation
Impact of intraoperative administration of inhaled nitric oxide (iNO) on patient hospital stay.
This will be measured by evaluating: • Length of ICU and hospital stay (measured in days).
Impact of intraoperative administration of inhaled nitric oxide (iNO) on in-hospital mortality
This will be measured by evaluating: -In-hospital mortality
Impact of intraoperative administration of inhaled nitric oxide (iNO) on liver function
This will be measured by evaluating: \- Peak serum ALT (Alanine Aminotransferase) and AST (Aspartate Aminotransferase) levels (measured in international units per litre (U/L)
Impact of intraoperative administration of inhaled nitric oxide (iNO) on blood clotting
This will be measured by evaluating the following: \- Time to INR (International Normalized Ratio) normalization
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