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PaNeX: Partial Nephrectomy Under Xenon (PaNeX)

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ClinicalTrials.gov Identifier: NCT01839084
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : February 18, 2016
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
RWTH Aachen University

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

Condition or disease Intervention/treatment Phase
Renal Function After Partial Nephrectomy Drug: Xenon Drug: Isoflurane Phase 3

Detailed Description:

A partial nephrectomy is accompanied by ischemia time, followed by reperfusion. This frequently leads to a kidney injury of the remained tissue and decrease of the renal function after surgery. As it was shown that Xenon has protective properties against ischemia/reperfusion injury, the investigators hypothesize that Xenon application during partial nephrectomy leads to a stronger nephroprotection than an anesthesia with Isoflurane.

The study will be conducted by two investigator types: The study enrollment and the post-anesthesia follow-up will be performed by Investigator I who is blinded to the study treatment. Investigator II will only perform general anesthesia for partial nephrectomy and will therefore necessarily be unblinded to the treatment conditions.

Patients will be randomly assigned to one of the following study groups. Group 1 (Xenon) will receive Xenon for maintenance of balanced anesthesia for partial nephrectomy. Group 2 (Isoflurane) will receive Isoflurane for the same surgery.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Xenon-anesthesia on the Renal Function After Partial Nephrectomy - PaNeX: Partial Nephrectomy Under Xenon:a Pilot Study
Study Start Date : July 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Experimental: Xenon
Gaseous anesthetic, dosage: 60% (v/v) in 40% oxygen, continuous application during surgery
Drug: Xenon
general anaesthesia with xenon 60% in oxygen (FiO2=0.4)
Other Name: Lenoxe

Active Comparator: Isoflurane
Inhalative anesthetic, dosage: 1.2% (v/v) in 40% oxygen/medical air , continuous application during surgery
Drug: Isoflurane
general anesthesia with isoflurane 1.2% in 40% oxygen/medical air
Other Name: Forene




Primary Outcome Measures :
  1. Evaluation of the impact of xenon-anesthesia on the renal function after partial nephrectomy, compared to an isoflurane-anesthesia. [ Time Frame: Within the first 7 postoperative days ]
    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.


Secondary Outcome Measures :
  1. Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: Intraoperatively ]
    Ischaemia time

  2. Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: Intraoperatively ]
    Duration of xenon/isoflurane exposition before and after the kidney ischemia time.

  3. Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: Intraoperatively until discharge from hospital ]
    Tumor size and histology, if applicable detection of hypoxia-inducible factor 1α (HIF-1α) in healthy resection border tissue

  4. Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: Intraoperatively and within the first 7 postoperative days ]
    Measurement of macrophage migration inhibitory factor (MIF) in serum

  5. Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: preaoperativ and Within the first 7 postoperative days ]
    Course of GFR determined with the Cystatin C value in serum

  6. Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: preaoperativ and Within the first 7 postoperative days ]
    Course of creatinine value in serum

  7. Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: Within the first 7 postoperative days ]
    Urine output within the first 48houres after surgery

  8. Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: Within the first 7 postoperative days ]
    If applicable determination of kidney injury molecule-1 (KIM-1)or neutrophil gelatinase-associated lipocalin (NGAL)

  9. Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: Within the first 7 postoperative days ]
    Determination of acute kidney failure according to the AKIN classification

  10. Safety criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: intraoperative ]
    Doses and concentration of study treatments

  11. Safety criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: intraoperative and within the first 7 postoperative days ]
    The peri-anaesthetic respiratory profile

  12. Safety criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: intraoperative and within the first 7 postoperative days ]
    The peri-anaesthetic haemodynamic profile

  13. Safety criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: intraoperative ]
    Intra-operative blood loss

  14. Safety criteria for using xenon-anaesthesia during partial nephrectomy. [ Time Frame: intraoperative and within the first 7 postoperative days ]
    The incidence of adverse event (AE) and serious adverse event (SAE)



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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:

  • 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

Exclusion Criteria:

  • 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

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): NCT01839084


Locations
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Germany
Department of Anesthesiology, University Hospital Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
German Research Foundation
Investigators
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Principal Investigator: Astrid Fahlenkamp, Dr. med. Department of Anesthesiology, University Hospital Aachen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01839084     History of Changes
Other Study ID Numbers: 12-051
2012-005698-30 ( EudraCT Number )
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016
Keywords provided by RWTH Aachen University:
Xenon
Isoflurane
Anesthetics, Inhalation
Nephroprotection
Partial nephrectomy
Xenon versus Isoflurane anesthesia
Additional relevant MeSH terms:
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Anesthetics
Xenon
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Inhalation
Anesthetics, General