A Phase 4 interventional study of Xenon and Desflurane in Liver Function After Partial Liver Resection, sponsored by RWTH Aachen University. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-29.
Sponsored by RWTH Aachen University · Phase 4, Interventional, and Treatment
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.
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Exclusion Criteria:
Subjects, fulfilling one or more of the following exclusion criteria will not be included in the study:
Xenon concentration of 50-60 % will be used for maintenance of general anesthesia and will be adjusted to maintain Bispectral index (BIS) value between 40 and 60.
Drug: Xenon
Desflurane concentrations of 4-5%/0.8 minimum alveolar concentration (MAC) respectively will be used for maintenance of general anesthesia and will be adjusted to maintain BIS index value between 40 and 60.
Drug: Desflurane
inhalation to maintain anesthesia
Also known as: LenoXe
inhalation to maintain anesthesia
Also known as: Suprane
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
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
Time frame: Surgery
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
Plan to share: No
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Start is estimated for Apr 2018.
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Studies of the drug tested here: Xenon