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

October 25, 2019 updated by: RWTH Aachen University

Xenon-anesthesia on Patients Undergoing Major Liver-resection: Randomized Controlled Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • University Hospital RWTH Aachen University, Department of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Suprane

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within the first 7 postoperative days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Surgery and ICU stay (maximum POD 7)
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)
Surgery and ICU stay (maximum POD 7)
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)
Surgery and ICU stay (maximum POD 7)
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)
Surgery and ICU stay (maximum POD 7)
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
Surgery
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
Surgery
Surgery time
Time Frame: Surgery
Difference in surgery time between study groups
Surgery
Fibrosis in the resected liver tissue
Time Frame: Surgery
Difference in fibrosis in the resected liver tissue between the two study arms
Surgery
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
Surgery
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
Surgery
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
Surgery
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
Surgery
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
Surgery
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
Surgery
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
Surgery
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
Surgery
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
Surgery
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
Surgery
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)
Within the first 7 postoperative days
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)
Within the first 7 postoperative days
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)
Within the first 7 postoperative days
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)
Within the first 7 postoperative days
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)
Within the first 7 postoperative days
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)
Within the first 7 postoperative days
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)
Within the first 7 postoperative days
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)
Within the first 7 postoperative days
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)
Within the first 7 postoperative days
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)
Within the first 7 postoperative days
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)
During ICU stay, maximum POD 7
Length of ICU stay
Time Frame: Until postoperative day 30
Difference in ICU length of stay between the two study arms
Until postoperative day 30
Length of hospital stay
Time Frame: Until postoperative day 30
Difference in hospital length of stay between the two study arms
Until postoperative day 30
Postoperative mortality
Time Frame: Until postoperative day 30
Difference in mortality between the two study arms until postoperative day 30
Until postoperative day 30
Adverse events
Time Frame: Until postoperative day 30
Difference in quality and quantity of adverse events between the two study arms
Until postoperative day 30
Difference in mortality, assessed by 30 days follow up via phone
Time Frame: Postoperative day 30
Difference in mortality between the two study arms
Postoperative day 30
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
Postoperative day 30
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
Postoperative day 30
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
Postoperative day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RWTH Aachen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ana Kowark, MD, RWTH Aachen University Hospital
  • Study Director: Mark Coburn, MD, PhD, RWTH Aachen University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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