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Xenon-anesthesia on Patients Undergoing Major Liver-resection (XeLiv)

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ClinicalTrials.gov Identifier: NCT03504033
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease Intervention/treatment Phase
Liver Function After Partial Liver Resection Drug: Xenon Drug: Desflurane Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-center, controlled, double-blinded, randomized, two-arm parallel, interventional clinical trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: This trial will be performed double-blinded. After randomization neither the patients nor the investigator of the baseline assessment and the postoperative assessment will be aware of the treatment allocation. The intraoperative anesthesiologist will not be blinded, due to feasibility and safety reasons.
Primary Purpose: Treatment
Official Title: Xenon-anesthesia on Patients Undergoing Major Liver-resection: Randomized Controlled Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Xenon
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
inhalation to maintain anesthesia
Other Name: LenoXe

Active Comparator: Desflurane
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
Other Name: Suprane




Primary Outcome Measures :
  1. Time-course of postoperative liver injury and function [ Time Frame: Within the first 7 postoperative days ]
    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.


Secondary Outcome Measures :
  1. Intra- and postoperative blood loss [ Time Frame: Surgery and ICU stay (maximum POD 7) ]
    Difference of intra- and postoperative blood loss between the two study arms until discharge from ICU or POD 7 (whichever occurs first)

  2. Quantity of intra- and postoperative infusions [ Time Frame: Surgery and ICU stay (maximum POD 7) ]
    Difference in quantity of infused crystalloids abd colloids between the two study arms until discharge from ICU or POD 7 (whichever occurs first)

  3. Quantity of intra- and postoperative blood products [ Time Frame: Surgery and ICU stay (maximum POD 7) ]
    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)

  4. Quantity of intra- and postoperative coagulation products [ Time Frame: Surgery and ICU stay (maximum POD 7) ]
    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)

  5. Necessity and duration of surgical pringle maneuver [ Time Frame: Surgery ]
    Difference in necessity and duration of intraoperative pringle maneuver performed by the surgeon between study groups

  6. Necessity and duration of surgical total vascular occlusion [ Time Frame: Surgery ]
    Difference in necessity and duration of intraoperative total vascular occlusion performed by the surgeon between study groups

  7. Surgery time [ Time Frame: Surgery ]
    Difference in surgery time between study groups

  8. Fibrosis in the resected liver tissue [ Time Frame: Surgery ]
    Difference in fibrosis in the resected liver tissue between the two study arms

  9. Number of hepatocytes in synthesis phase in the resected liver tissue [ Time Frame: Surgery ]
    Difference in number of hepatocytes in synthesis phase in the resected liver tissue between the two study arms

  10. Number of macrophages in the resected liver tissue [ Time Frame: Surgery ]
    Difference in number of macrophages in the resected liver tissue between the two study arms

  11. Expression of Interleukin 6 (IL-6) in the resected liver tissue [ Time Frame: Surgery ]
    Difference in expression of Interleukin 6 (IL-6) in the resected liver tissue between the two study arms

  12. Expression of tumor necrosis factor (TNF) in the resected liver tissue [ Time Frame: Surgery ]
    Difference in expression of tumor necrosis factor (TNF) in the resected liver tissue between the two study arms

  13. Expression of hepatocyte growth factor (HGF) in the resected liver tissue [ Time Frame: Surgery ]
    Difference in expression of hepatocyte growth factor (HGF) in the resected liver tissue between the two study arms

  14. Expression of epidermal growth factor (EGF) in the resected liver tissue [ Time Frame: Surgery ]
    Difference in expression of epidermal growth factor (EGF) in the resected liver tissue between the two study arms

  15. Expression of fibroblast growth factor (FGF) in the resected liver tissue [ Time Frame: Surgery ]
    Difference in expression of fibroblast growth factor (FGF) in the resected liver tissue between the two study arms

  16. Expression of insulin-like growth factors I/II (IGF-I/II) in the resected liver tissue [ Time Frame: Surgery ]
    Difference in expression of insulin-like growth factors I/II (IGF-I/II) in the resected liver tissue between the two study arms

  17. Weight of the resected liver tissue [ Time Frame: Surgery ]
    Difference in weight of the resected liver tissue normalized to body weight (%BW) between the two study arms

  18. Computer tomography-assisted planimetry of the resected liver tissue [ Time Frame: Surgery ]
    Difference in area of the resected liver tissue, assessed with computer tomography assisted planimetry, between the two study arms

  19. Time-course of hemoglobin (Hb) [ Time Frame: Within the first 7 postoperative days ]
    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)

  20. Time-course of platelet count [ Time Frame: Within the first 7 postoperative days ]
    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)

  21. Time-course of prothrombin time (PT) [ Time Frame: Within the first 7 postoperative days ]
    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)

  22. Time-course of partial thromboplastin time (PTT) [ Time Frame: Within the first 7 postoperative days ]
    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)

  23. Time-course of bilirubin [ Time Frame: Within the first 7 postoperative days ]
    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)

  24. Time-course of aspartate aminotransferase (ASAT) [ Time Frame: Within the first 7 postoperative days ]
    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)

  25. Time-course of creatinine [ Time Frame: Within the first 7 postoperative days ]
    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)

  26. Time-course of lactate [ Time Frame: Within the first 7 postoperative days ]
    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)

  27. Time-course of albumin [ Time Frame: Within the first 7 postoperative days ]
    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)

  28. Time-course of international normalized ratio (INR) [ Time Frame: Within the first 7 postoperative days ]
    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)

  29. Postoperative peak of blood lactate [ Time Frame: During ICU stay, maximum POD 7 ]
    Difference in postoperative peak of blood lactate between the two study groups until discharge from ICU or POD 7 (whichever occurs first)

  30. Length of ICU stay [ Time Frame: Until postoperative day 30 ]
    Difference in ICU length of stay between the two study arms

  31. Length of hospital stay [ Time Frame: Until postoperative day 30 ]
    Difference in hospital length of stay between the two study arms

  32. Postoperative mortality [ Time Frame: Until postoperative day 30 ]
    Difference in mortality between the two study arms until postoperative day 30

  33. Adverse events [ Time Frame: Until postoperative day 30 ]
    Difference in quality and quantity of adverse events between the two study arms

  34. Difference in mortality, assessed by 30 days follow up via phone [ Time Frame: Postoperative day 30 ]
    Difference in mortality between the two study arms

  35. Difference in coagulation disorder, assessed by 30 days follow up via phone [ Time Frame: Postoperative day 30 ]
    Difference in coagulation disorder between the two study arms

  36. Difference in re-admission to hospital, assessed by 30 days follow up via phone [ Time Frame: Postoperative day 30 ]
    Difference in re-admission to hospital between the two study arms

  37. Difference in other adverse events, assessed by 30 days follow up via phone [ Time Frame: Postoperative day 30 ]
    Difference in other adverse events between the two study arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504033


Contacts
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Contact: Sebastian Ziemann, MD +492418088179 sziemann@ukaachen.de
Contact: Ana Kowark, MD +492418088179 akowark@ukaachen.de

Locations
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Germany
University Hospital RWTH Aachen University, Department of Anesthesiology Not yet recruiting
Aachen, Germany, 52074
Contact: Sebastian Ziemann, MD    +49 241 80 88179    sziemann@ukaachen.de   
Contact: Ana Kowark, MD    +49 241 80 88179    akowark@ukaachen.de   
Principal Investigator: Ana Kowark, MD         
Sub-Investigator: Rolf Rossaint, MD         
Sub-Investigator: Mark Coburn, MD         
Sub-Investigator: Julia Van Waesberghe, MD         
Sub-Investigator: Sebastian Ziemann, MD         
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Ana Kowark, MD RWTH Aachen University Hospital
Study Director: Mark Coburn, MD, PhD RWTH Aachen University Hospital

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03504033     History of Changes
Other Study ID Numbers: 15-163
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RWTH Aachen University:
Xenon
Liver resection
post-operative liver failure
anesthetics, inhalation
Desflurane
Randomized controlled trail
RCT

Additional relevant MeSH terms:
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Anesthetics
Benzocaine
Desflurane
Xenon
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation
Anesthetics, General