NCT01839084

Brief Summary

Purpose of this study is to determine whether Xenon - as compared to Isoflurane - shows a nephroprotection after partial nephrectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

2.6 years

First QC Date

April 9, 2013

Last Update Submit

February 17, 2016

Conditions

Renal Function After Partial Nephrectomy

Keywords

XenonIsofluraneAnesthetics, InhalationNephroprotectionPartial nephrectomyXenon versus Isoflurane anesthesia

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the impact of xenon-anesthesia on the renal function after partial nephrectomy, compared to an isoflurane-anesthesia.

    Evaluation of the maximum decrease of glomerular filtration rate (GFR) within 7 days after partial nephrectomy surgery. Maximum decrease will be assessed by the difference between the baseline value of GFR and the minimum value of GFR after surgery.

    Within the first 7 postoperative days

Secondary Outcomes (14)

  • Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.

    Intraoperatively

  • Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.

    Intraoperatively

  • Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.

    Intraoperatively until discharge from hospital

  • Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.

    Intraoperatively and within the first 7 postoperative days

  • Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.

    preaoperativ and Within the first 7 postoperative days

  • +9 more secondary outcomes

Study Arms (2)

Xenon

EXPERIMENTAL

Gaseous anesthetic, dosage: 60% (v/v) in 40% oxygen, continuous application during surgery

Drug: Xenon

Isoflurane

ACTIVE COMPARATOR

Inhalative anesthetic, dosage: 1.2% (v/v) in 40% oxygen/medical air , continuous application during surgery

Drug: Isoflurane

Interventions

XenonDRUG

general anaesthesia with xenon 60% in oxygen (FiO2=0.4)

Also known as: Lenoxe
Xenon
IsofluraneDRUG

general anesthesia with isoflurane 1.2% in 40% oxygen/medical air

Also known as: Forene
Isoflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients willing and able to complete the requirements of this study
  • Patients with renal carcinoma restricted to one kidney
  • Patients undergoing partial nephrectomy
  • Men and women \>= 18 yrs
  • Informed consent

You may not qualify if:

  • Chronic renal failure with a GFR \< 60ml/min/1,73m2 body surface area
  • American Society of Anesthesiologists (ASA)\>III
  • Hypersensitivity to the study anaesthetics
  • Chronic obstructive pulmonary disease (COPD) GOLD IV
  • Acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
  • Severe cardial dysfunction New York Heart Association (NYHA) \>III
  • Disabling neuropsychiatric disorders
  • Increased intracranial pressure
  • pregnant or breastfeeding women
  • Women of childbearing potential
  • Presumed uncooperativeness or legal incapacity
  • Lack of informed consent
  • Participation in a concomitant trial within the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (2)

  • Schafer P, Fahlenkamp A, Rossaint R, Coburn M, Kowark A. Better haemodynamic stability under xenon anaesthesia than under isoflurane anaesthesia during partial nephrectomy - a secondary analysis of a randomised controlled trial. BMC Anesthesiol. 2019 Jul 9;19(1):125. doi: 10.1186/s12871-019-0799-2.

    PMID: 31288740DERIVED

  • Stevanovic A, Schaefer P, Coburn M, Rossaint R, Stoppe C, Boor P, Pfister D, Heidenreich A, Christ H, Hellmich M, Fahlenkamp AV. Renal function following xenon anesthesia for partial nephrectomy-An explorative analysis of a randomized controlled study. PLoS One. 2017 Jul 18;12(7):e0181022. doi: 10.1371/journal.pone.0181022. eCollection 2017.

    PMID: 28719609DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

XenonIsoflurane

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Noble GasesElementsInorganic ChemicalsGasesMethyl EthersEthersOrganic Chemicals

Study Officials

  • Astrid Fahlenkamp, Dr. med.

    Department of Anesthesiology, University Hospital Aachen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 24, 2013

Study Start

July 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 18, 2016

Record last verified: 2016-02

Locations

DE(1)