- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01839084
PaNeX: Partial Nephrectomy Under Xenon (PaNeX)
Impact of Xenon-anesthesia on the Renal Function After Partial Nephrectomy - PaNeX: Partial Nephrectomy Under Xenon:a Pilot Study
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
NRW
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Aachen, NRW, Germany, 52074
- Department of Anesthesiology, University Hospital Aachen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
Active Comparator: Isoflurane
Inhalative anesthetic, dosage: 1.2% (v/v) in 40% oxygen/medical air , continuous application during surgery
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general anesthesia with isoflurane 1.2% in 40% oxygen/medical air
Other Names:
|
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.
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Within the first 7 postoperative days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Time Frame: Intraoperatively
|
Ischaemia time
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Intraoperatively
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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.
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Intraoperatively
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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
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Intraoperatively until discharge from hospital
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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
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Within the first 7 postoperative days
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Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Time Frame: Within the first 7 postoperative days
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If applicable determination of kidney injury molecule-1 (KIM-1)or neutrophil gelatinase-associated lipocalin (NGAL)
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Within the first 7 postoperative days
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Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Time Frame: Within the first 7 postoperative days
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Determination of acute kidney failure according to the AKIN classification
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Within the first 7 postoperative days
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Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Time Frame: intraoperative
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Doses and concentration of study treatments
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intraoperative
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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
Sponsor
Collaborators
Investigators
- Principal Investigator: Astrid Fahlenkamp, Dr. med., Department of Anesthesiology, University Hospital Aachen
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-051
- 2012-005698-30 (EudraCT Number)
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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