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Completed

NCT Number: NCT01839084

PaNeX: Partial Nephrectomy Under Xenon

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Anesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xenon

Drug

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

Other names: Lenoxe

Isoflurane

Drug

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

Other names: Forene

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

Impact of Xenon-anesthesia on the Renal Function After Partial Nephrectomy - PaNeX: Partial Nephrectomy Under Xenon:a Pilot Study

Acronym: PaNeX

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 24, 2013
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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