PaNeX: Partial Nephrectomy Under Xenon (PaNeX)

February 17, 2016 updated by: RWTH Aachen University

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

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

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 3

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

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

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xenon
Gaseous anesthetic, dosage: 60% (v/v) in 40% oxygen, continuous application during surgery
general anaesthesia with xenon 60% in oxygen (FiO2=0.4)
Other Names:
  • Lenoxe
Active Comparator: Isoflurane
Inhalative anesthetic, dosage: 1.2% (v/v) in 40% oxygen/medical air , continuous application during surgery
general anesthesia with isoflurane 1.2% in 40% oxygen/medical air
Other Names:
  • Forene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first 7 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Time Frame: Intraoperatively
Ischaemia time
Intraoperatively
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.
Intraoperatively
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
Intraoperatively until discharge from hospital
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
Intraoperatively and within the first 7 postoperative days
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
preaoperativ and Within the first 7 postoperative days
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
preaoperativ and Within the first 7 postoperative days
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
Within the first 7 postoperative days
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)
Within the first 7 postoperative days
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
Within the first 7 postoperative days
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Time Frame: intraoperative
Doses and concentration of study treatments
intraoperative
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Time Frame: intraoperative and within the first 7 postoperative days
The peri-anaesthetic respiratory profile
intraoperative and within the first 7 postoperative days
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Time Frame: intraoperative and within the first 7 postoperative days
The peri-anaesthetic haemodynamic profile
intraoperative and within the first 7 postoperative days
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Time Frame: intraoperative
Intra-operative blood loss
intraoperative
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)
intraoperative and within the first 7 postoperative days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Astrid Fahlenkamp, Dr. med., Department of Anesthesiology, University Hospital Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

July 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 19, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

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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