Clinical trial NCT03504033: Xenon-anesthesia on Patients Undergoing Major Liver-resection
Official title: Xenon-anesthesia on Patients Undergoing Major Liver-resection: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Liver Function After Partial Liver Resection
Keywords: Xenon
Liver resection
post-operative liver failure
anesthetics, inhalation
Desflurane
Randomized controlled trail
RCT
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, controlled, double-blinded, randomized, two-arm parallel, interventional clinical trial
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time-course of postoperative liver injury and function
timeFrame: Within the first 7 postoperative days
Secondary outcomes:
measure: Intra- and postoperative blood loss
timeFrame: Surgery and ICU stay (maximum POD 7)
measure: Quantity of intra- and postoperative infusions
timeFrame: Surgery and ICU stay (maximum POD 7)
measure: Quantity of intra- and postoperative blood products
timeFrame: Surgery and ICU stay (maximum POD 7)
measure: Quantity of intra- and postoperative coagulation products
timeFrame: Surgery and ICU stay (maximum POD 7)
measure: Necessity and duration of surgical pringle maneuver
timeFrame: Surgery
measure: Necessity and duration of surgical total vascular occlusion
timeFrame: Surgery
measure: Surgery time
timeFrame: Surgery
measure: Fibrosis in the resected liver tissue
timeFrame: Surgery
measure: Number of hepatocytes in synthesis phase in the resected liver tissue
timeFrame: Surgery
measure: Number of macrophages in the resected liver tissue
timeFrame: Surgery
measure: Expression of Interleukin 6 (IL-6) in the resected liver tissue
timeFrame: Surgery
measure: Expression of tumor necrosis factor (TNF) in the resected liver tissue
timeFrame: Surgery
measure: Expression of hepatocyte growth factor (HGF) in the resected liver tissue
timeFrame: Surgery
measure: Expression of epidermal growth factor (EGF) in the resected liver tissue
timeFrame: Surgery
measure: Expression of fibroblast growth factor (FGF) in the resected liver tissue
timeFrame: Surgery
measure: Expression of insulin-like growth factors I/II (IGF-I/II) in the resected liver tissue
timeFrame: Surgery
measure: Weight of the resected liver tissue
timeFrame: Surgery
measure: Computer tomography-assisted planimetry of the resected liver tissue
timeFrame: Surgery
measure: Time-course of hemoglobin (Hb)
timeFrame: Within the first 7 postoperative days
measure: Time-course of platelet count
timeFrame: Within the first 7 postoperative days
measure: Time-course of prothrombin time (PT)
timeFrame: Within the first 7 postoperative days
measure: Time-course of partial thromboplastin time (PTT)
timeFrame: Within the first 7 postoperative days
measure: Time-course of bilirubin
timeFrame: Within the first 7 postoperative days
measure: Time-course of aspartate aminotransferase (ASAT)
timeFrame: Within the first 7 postoperative days
measure: Time-course of creatinine
timeFrame: Within the first 7 postoperative days
measure: Time-course of lactate
timeFrame: Within the first 7 postoperative days
measure: Time-course of albumin
timeFrame: Within the first 7 postoperative days
measure: Time-course of international normalized ratio (INR)
timeFrame: Within the first 7 postoperative days
measure: Postoperative peak of blood lactate
timeFrame: During ICU stay, maximum POD 7
measure: Length of ICU stay
timeFrame: Until postoperative day 30
measure: Length of hospital stay
timeFrame: Until postoperative day 30
measure: Postoperative mortality
timeFrame: Until postoperative day 30
measure: Adverse events
timeFrame: Until postoperative day 30
measure: Difference in mortality, assessed by 30 days follow up via phone
timeFrame: Postoperative day 30
measure: Difference in coagulation disorder, assessed by 30 days follow up via phone
timeFrame: Postoperative day 30
measure: Difference in re-admission to hospital, assessed by 30 days follow up via phone
timeFrame: Postoperative day 30
measure: Difference in other adverse events, assessed by 30 days follow up via phone
timeFrame: Postoperative day 30
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen University, Department of Anesthesiology
Study officials:
affiliation: RWTH Aachen University Hospital
name: Ana Kowark, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RWTH Aachen University Hospital
name: Mark Coburn, MD, PhD
role: STUDY_DIRECTOR
References: