post-resectional liver failure
Conditions
Interventions
Trade Name: LENOXe 100% (V/V)
Pharmaceutical Form: Inhalation vapour, liquid
CAS Number: 7440-63-3
Other descriptive name: XENON
Concentration unit: % (V/V) percent volume/volume
Concentration type: e
Sponsors
RWTH Aachen, represented by the Rector, himself represented by the Dean of the Medical Faculty
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. = 3 segment resection 2. = 18 years 3. Both gender 4. ASA I-III 5. Written informed consent prior to study participation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 74 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 74
Exclusion criteria
Exclusion criteria: 1. Severe pulmonary or airway disease 2. Severe liver disease, accompanied by a Child–Pugh class >A 3. Allergy/hypersensitivity to study medications 4. ASA > III 5. Patients susceptible to malignant hyperthermia 6. Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods 7. Patients with elevated intracranial pressure 8. Patients legally unable to give written informed consent. 9. Patients with preeclampsia or eclampsia 10. Patients with a risk of high oxygen demand 11. Patients with seriously impaired cardiac function 12. All contraindications for xenon anesthesia according to the summary of product characteristics LENOXe 13. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess if xenon is superior in order to decrease the incidence of a post-resectional liver failure in contrast to desflurane;Secondary Objective: if xenon is superior regarding the outcomes (like mortality, length of hospital stay, postoperative adverse events, maximum liver function postoperative) compared to desflurane;Primary end point(s): postoperative liver injury and function after major liver resection until day 7;Timepoint(s) of evaluation of this end point: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Perioperative laboratory data Pathohistology of the resected liver tissue Asservation of remnants of the resected liver tissue for further laboratory analyzes Weight of resected liver tissue normalized to body weight (%BW) and planimetry with computer tomography Intraoperative and postoperative blood loss Optional LiMAx test POD 42 Quantity of infused crystalloids, colloids, units of transfused packed red blood cells, fresh frozen plasma and platelet concentrates Postoperative adverse events Mortality Length of stay ;Timepoint(s) of evaluation of this end point: 30 days | — |
Countries
Germany
Contacts
Public ContactCTC-A
Center for Translational & Clinical Research Aachen
Outcome results
None listed