Renal Function After Partial NephrectomyPhase 3PaNeXNCT01839084
PaNeX: Partial Nephrectomy Under Xenon
A Phase 3 study testing Xenon and Isoflurane in people with Renal Function After Partial Nephrectomy, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Purpose of this study is to determine whether Xenon - as compared to Isoflurane - shows a nephroprotection after partial nephrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Function After Partial Nephrectomy
- What is being tested?
- Xenon and Isoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Feb 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Function After Partial Nephrectomy
- Being tested
- Xenon, Isoflurane
- Keywords
- Xenon, Isoflurane, Anesthetics, Inhalation, Nephroprotection, Partial nephrectomy, Xenon versus Isoflurane anesthesia
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonDrug
Also called Lenoxe
general anaesthesia with xenon 60% in oxygen (FiO2=0.4)
IsofluraneDrug
Also called Forene
general anesthesia with isoflurane 1.2% in 40% oxygen/medical air
| Study group | Role | What they receive |
|---|---|---|
| Xenon | Experimental | Gaseous anesthetic, dosage: 60% (v/v) in 40% oxygen, continuous application during surgery Receives: Drug: Xenon |
| Isoflurane | Active comparator | Inhalative anesthetic, dosage: 1.2% (v/v) in 40% oxygen/medical air , continuous application during surgery Receives: Drug: Isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the first 7 postoperative days
Secondary outcomes (14)
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Ischaemia time
Measured: Intraoperatively
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Duration of xenon/isoflurane exposition before and after the kidney ischemia time.
Measured: Intraoperatively
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Tumor size and histology, if applicable detection of hypoxia-inducible factor 1α (HIF-1α) in healthy resection border tissue
Measured: Intraoperatively until discharge from hospital
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Measurement of macrophage migration inhibitory factor (MIF) in serum
Measured: Intraoperatively and within the first 7 postoperative days
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Course of GFR determined with the Cystatin C value in serum
Measured: preaoperativ and Within the first 7 postoperative days
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Course of creatinine value in serum
Measured: preaoperativ and Within the first 7 postoperative days
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Urine output within the first 48houres after surgery
Measured: Within the first 7 postoperative days
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
If applicable determination of kidney injury molecule-1 (KIM-1)or neutrophil gelatinase-associated lipocalin (NGAL)
Measured: Within the first 7 postoperative days
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Determination of acute kidney failure according to the AKIN classification
Measured: Within the first 7 postoperative days
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Doses and concentration of study treatments
Measured: intraoperative
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
The peri-anaesthetic respiratory profile
Measured: intraoperative and within the first 7 postoperative days
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
The peri-anaesthetic haemodynamic profile
Measured: intraoperative and within the first 7 postoperative days
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Intra-operative blood loss
Measured: intraoperative
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
The incidence of adverse event (AE) and serious adverse event (SAE)
Measured: intraoperative and within the first 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Function After Partial NephrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Astrid Fahlenkamp, Dr. med., Principal investigator, Department of Anesthesiology, University Hospital Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839084
- Sponsor's protocol ID
- 12-051
- Other IDs
- 2012-005698-30
- Acronym
- PaNeX
- Status last verified
- Feb 2016
- First submitted
- 9 Apr 2013
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31288740Stevanovic 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.
PubMed 28719609
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Xenon-anesthesia on the Renal Function After Partial Nephrectomy - PaNeX: Partial Nephrectomy Under Xenon:a Pilot Study
- ClinicalTrials.gov ID
- NCT01839084
- Acronym / sponsor ID
- PaNeX / 12-051
- Conditions
- Renal Function After Partial Nephrectomy
- Keywords
- Xenon, Isoflurane, Anesthetics, Inhalation, Nephroprotection, Partial nephrectomy, Xenon versus Isoflurane anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jul 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of this study is to determine whether Xenon - as compared to Isoflurane - shows a nephroprotection after partial nephrectomy.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenon | Experimental | Drug: XenonGaseous anesthetic, dosage: 60% (v/v) in 40% oxygen, continuous application during surgery |
| Isoflurane | Active comparator | Drug: IsofluraneInhalative anesthetic, dosage: 1.2% (v/v) in 40% oxygen/medical air , continuous application during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XenonAlso: Lenoxegeneral anaesthesia with xenon 60% in oxygen (FiO2=0.4) | Drug | Xenon |
| IsofluraneAlso: Forenegeneral anesthesia with isoflurane 1.2% in 40% oxygen/medical air | Drug | Isoflurane |
Primary outcome
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.
14 secondary outcomes
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Time frame: Intraoperatively
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Time frame: Intraoperatively
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Time frame: 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
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Time frame: 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
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Time frame: Within the first 7 postoperative days
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Time frame: Within the first 7 postoperative days
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Time frame: Within the first 7 postoperative days
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Time frame: intraoperative
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Time frame: 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
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Time frame: intraoperative
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Time frame: intraoperative and within the first 7 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Derived from this study: PubMed 31288740Schafer 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.
- Derived from this study: PubMed 28719609Stevanovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrid Fahlenkamp, Dr. med. principal investigator
Department of Anesthesiology, University Hospital Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xenon and Isoflurane in people with Renal Function After Partial Nephrectomy, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01839084, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.