PaNeX: Partial Nephrectomy Under Xenon (PaNeX)

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

Germany

Department of Anesthesiology, University Hospital Aachen

Aachen, NRW, Germany, 52074

Sponsors and Collaborators

RWTH Aachen University

German Research Foundation

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schäfer 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.

• Responsible Party: RWTH Aachen University
• ClinicalTrials.gov Identifier: NCT01839084
• Other Study ID Numbers: 12-051; 2012-005698-30 ( EudraCT Number )
• First Posted: April 24, 2013
• 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:

Isoflurane; Anesthetics, Inhalation; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs