Liver Function After Partial Liver Resection Clinical Trial
— XeLivOfficial title:
Xenon-anesthesia on Patients Undergoing Major Liver-resection: Randomized Controlled Trial
| Verified date | October 2019 |
| Source | RWTH Aachen University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of this study is to compare the postoperative outcome of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 27, 2019 |
| Est. primary completion date | September 27, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital RWTH Aachen University, Department of Anesthesiology | Aachen |
| Lead Sponsor | Collaborator |
|---|---|
| RWTH Aachen University |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Within the first 7 postoperative days | |
| Secondary | 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) | Surgery and ICU stay (maximum POD 7) | |
| Secondary | 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) | Surgery and ICU stay (maximum POD 7) | |
| Secondary | 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) | Surgery and ICU stay (maximum POD 7) | |
| Secondary | 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) | Surgery and ICU stay (maximum POD 7) | |
| Secondary | Necessity and duration of surgical pringle maneuver | Difference in necessity and duration of intraoperative pringle maneuver performed by the surgeon between study groups | Surgery | |
| Secondary | 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 | Surgery | |
| Secondary | Surgery time | Difference in surgery time between study groups | Surgery | |
| Secondary | Fibrosis in the resected liver tissue | Difference in fibrosis in the resected liver tissue between the two study arms | Surgery | |
| Secondary | 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 | Surgery | |
| Secondary | Number of macrophages in the resected liver tissue | Difference in number of macrophages in the resected liver tissue between the two study arms | Surgery | |
| Secondary | 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 | Surgery | |
| Secondary | 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 | Surgery | |
| Secondary | 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 | Surgery | |
| Secondary | 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 | Surgery | |
| Secondary | 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 | Surgery | |
| Secondary | 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 | Surgery | |
| Secondary | Weight of the resected liver tissue | Difference in weight of the resected liver tissue normalized to body weight (%BW) between the two study arms | Surgery | |
| Secondary | 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 | Surgery | |
| Secondary | 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) | Within the first 7 postoperative days | |
| Secondary | 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) | Within the first 7 postoperative days | |
| Secondary | 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) | Within the first 7 postoperative days | |
| Secondary | 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) | Within the first 7 postoperative days | |
| Secondary | 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) | Within the first 7 postoperative days | |
| Secondary | 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) | Within the first 7 postoperative days | |
| Secondary | 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) | Within the first 7 postoperative days | |
| Secondary | 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) | Within the first 7 postoperative days | |
| Secondary | 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) | Within the first 7 postoperative days | |
| Secondary | 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) | Within the first 7 postoperative days | |
| Secondary | 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) | During ICU stay, maximum POD 7 | |
| Secondary | Length of ICU stay | Difference in ICU length of stay between the two study arms | Until postoperative day 30 | |
| Secondary | Length of hospital stay | Difference in hospital length of stay between the two study arms | Until postoperative day 30 | |
| Secondary | Postoperative mortality | Difference in mortality between the two study arms until postoperative day 30 | Until postoperative day 30 | |
| Secondary | Adverse events | Difference in quality and quantity of adverse events between the two study arms | Until postoperative day 30 | |
| Secondary | Difference in mortality, assessed by 30 days follow up via phone | Difference in mortality between the two study arms | Postoperative day 30 | |
| Secondary | Difference in coagulation disorder, assessed by 30 days follow up via phone | Difference in coagulation disorder between the two study arms | Postoperative day 30 | |
| Secondary | 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 | Postoperative day 30 | |
| Secondary | Difference in other adverse events, assessed by 30 days follow up via phone | Difference in other adverse events between the two study arms | Postoperative day 30 |