Xenon-anesthesia on Patients Undergoing Major Liver-resection

RWTH Aachen University

Overview

The aim of this study is to compare the postoperative outcome of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia.

The aim of this study is to compare the postoperative liver function and additional outcome parameters of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia. Xenon is known to maintain hemodynamic stability and consecutive tissue perfusion. Together with its potential for ischemic pre-conditioning, we hypothesize a protective effect of xenon on post-operative liver failure and ischemia/reperfusion injury.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Liver Function After Partial Liver Resection

Interventions

XenonDRUG

inhalation to maintain anesthesia

DesfluraneDRUG

inhalation to maintain anesthesia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥ 3 segments liver resection * ≥ 18 years * Both gender * American Society of Anesthesiologists (ASA) classification I-III * Written informed consent prior to study participation Exclusion Criteria: Subjects, fulfilling one or more of the following exclusion criteria will not be included in the study: * Severe pulmonary or airway disease * Severe liver disease, accompanied by a Child-Pugh class \>A * Allergy/hypersensitivity to study medications * ASA ≥ IV * Patients susceptible to malignant hyperthermia * Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods * Patients with preeclampsia or eclampsia * Patients legally unable to give written informed consent. * Patients with risk of high oxygen demand * Patient with seriously impaired cardiac function * All contraindications for xenon anesthesia according to the summary of product characteristics LENOXe * Patient participates in a parallel interventional clinical trial during this study or receives an investigational drug within 30 days prior to inclusion into this study

Locations (1)

University Hospital RWTH Aachen University, Department of Anesthesiology

Aachen, Germany

Outcomes

Primary Outcomes

Time-course of postoperative liver injury and function

The primary study outcome is the difference in postoperative liver injury and function between the two study arms, measured by the perioperative time-course of the liver transaminase alanine-aminotransferase (ALAT) preoperative and on postoperative days (POD) 1-3, 5 and 7.

Time frame: Within the first 7 postoperative days

Secondary Outcomes

Intra- and postoperative blood loss

Difference of intra- and postoperative blood loss between the two study arms until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Surgery and ICU stay (maximum POD 7)

Quantity of intra- and postoperative infusions

Difference in quantity of infused crystalloids abd colloids between the two study arms until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Surgery and ICU stay (maximum POD 7)

Quantity of intra- and postoperative blood products

Difference in quantity of transfused packed red blood cells (RBCs), fresh frozen plasma (FFP) and platelet concentrates between the two study arms until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Surgery and ICU stay (maximum POD 7)

Quantity of intra- and postoperative coagulation products

Difference in quantity of administered tranexamic acid, fibrinogen and prothrombin complex concentrates between the two study arms until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Surgery and ICU stay (maximum POD 7)

Necessity and duration of surgical pringle maneuver

Difference in necessity and duration of intraoperative pringle maneuver performed by the surgeon between study groups

Data from ClinicalTrials.gov

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Necessity and duration of surgical total vascular occlusion

Difference in necessity and duration of intraoperative total vascular occlusion performed by the surgeon between study groups

Time frame: Surgery

Surgery time

Difference in surgery time between study groups

Time frame: Surgery

Fibrosis in the resected liver tissue

Difference in fibrosis in the resected liver tissue between the two study arms

Time frame: Surgery

Number of hepatocytes in synthesis phase in the resected liver tissue

Difference in number of hepatocytes in synthesis phase in the resected liver tissue between the two study arms

Time frame: Surgery

Number of macrophages in the resected liver tissue

Difference in number of macrophages in the resected liver tissue between the two study arms

Time frame: Surgery

Expression of Interleukin 6 (IL-6) in the resected liver tissue

Difference in expression of Interleukin 6 (IL-6) in the resected liver tissue between the two study arms

Time frame: Surgery

Expression of tumor necrosis factor (TNF) in the resected liver tissue

Difference in expression of tumor necrosis factor (TNF) in the resected liver tissue between the two study arms

Time frame: Surgery

Expression of hepatocyte growth factor (HGF) in the resected liver tissue

Difference in expression of hepatocyte growth factor (HGF) in the resected liver tissue between the two study arms

Time frame: Surgery

Expression of epidermal growth factor (EGF) in the resected liver tissue

Difference in expression of epidermal growth factor (EGF) in the resected liver tissue between the two study arms

Time frame: Surgery

Expression of fibroblast growth factor (FGF) in the resected liver tissue

Difference in expression of fibroblast growth factor (FGF) in the resected liver tissue between the two study arms

Time frame: Surgery

Expression of insulin-like growth factors I/II (IGF-I/II) in the resected liver tissue

Difference in expression of insulin-like growth factors I/II (IGF-I/II) in the resected liver tissue between the two study arms

Time frame: Surgery

Weight of the resected liver tissue

Difference in weight of the resected liver tissue normalized to body weight (%BW) between the two study arms

Time frame: Surgery

Computer tomography-assisted planimetry of the resected liver tissue

Difference in area of the resected liver tissue, assessed with computer tomography assisted planimetry, between the two study arms

Time frame: Surgery

Time-course of hemoglobin (Hb)

Difference in laboratory data, measured by the time-course of hemoglobin (Hb), between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Within the first 7 postoperative days

Time-course of platelet count

Difference in laboratory data, measured by the time-course of platelet count, between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Within the first 7 postoperative days

Time-course of prothrombin time (PT)

Difference in laboratory data, measured by the time-course of prothrombin time (PT), between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Within the first 7 postoperative days

Time-course of partial thromboplastin time (PTT)

Difference in laboratory data, measured by the time-course of partial thromboplastin time (PTT), between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Within the first 7 postoperative days

Time-course of bilirubin

Difference in laboratory data, measured by the time-course of bilirubin, between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Within the first 7 postoperative days

Time-course of aspartate aminotransferase (ASAT)

Difference in laboratory data, measured by the time-course of aspartate aminotransferase (ASAT), between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Within the first 7 postoperative days

Time-course of creatinine

Difference in laboratory data, measured by the time-course of creatinine, between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Within the first 7 postoperative days

Time-course of lactate

Difference in laboratory data, measured by the time-course of lactate, between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Within the first 7 postoperative days

Time-course of albumin

Difference in laboratory data, measured by the time-course of albumin, between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Within the first 7 postoperative days

Time-course of international normalized ratio (INR)

Difference in laboratory data, measured by the time-course of international normalized ratio (INR) levels, between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)

Time frame: Within the first 7 postoperative days

Postoperative peak of blood lactate

Difference in postoperative peak of blood lactate between the two study groups until discharge from ICU or POD 7 (whichever occurs first)

Time frame: During ICU stay, maximum POD 7

Length of ICU stay

Difference in ICU length of stay between the two study arms

Time frame: Until postoperative day 30

Length of hospital stay

Difference in hospital length of stay between the two study arms

Time frame: Until postoperative day 30

Postoperative mortality

Difference in mortality between the two study arms until postoperative day 30

Time frame: Until postoperative day 30

Adverse events

Difference in quality and quantity of adverse events between the two study arms

Time frame: Until postoperative day 30

Difference in mortality, assessed by 30 days follow up via phone

Difference in mortality between the two study arms

Time frame: Postoperative day 30

Difference in coagulation disorder, assessed by 30 days follow up via phone

Difference in coagulation disorder between the two study arms

Time frame: Postoperative day 30

Difference in re-admission to hospital, assessed by 30 days follow up via phone

Difference in re-admission to hospital between the two study arms

Time frame: Postoperative day 30

Difference in other adverse events, assessed by 30 days follow up via phone

Difference in other adverse events between the two study arms

Time frame: Postoperative day 30