E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
renal function after partial nephrectomy |
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E.1.1.1 | Medical condition in easily understood language |
investigation of renal function after removing a broken part of the kindey |
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E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034072 |
E.1.2 | Term | Partial nephrectomy |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate, if an anaesthesia conducted with xenon has a positive influence of the postoperative renal function |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- signed informed consent - renal carcinoma - planned surgery: partial nephrectomy - male or female patients aged > 18 years old - ability to understand and to follow the instructions of the staff |
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E.4 | Principal exclusion criteria |
- renal failure with a glomerular filtration rate < 60 ml/min/1,73 m² body surface - American Society of Anesthesiologists (ASA) Status > III - known contra-indications and allergies against Propofol, Sufentanil, Xenon, Isoflurane or Rocuronium - severe cardiac disorder (New York Heart Association NYHA IV), acute coronary syndrome during the last 24h, hemodynamic instability, need for an inotropic support - severe lung and pulmonary deseases (FeV1/FVC < 70% and FeV1 < 30% of the desired value), or severe chronic respiratory insufficiency with PaO2 <60mmHg, or home based oxygen therapy - severe neurological disorders - increase intracranial pressure - disposition to malignant hyperthermia - pregnant or breast feeding women - unability to give consent - patients who disagree with the conduct of the study - participation in further trials during the last 30 days - problems concerning the language and the communication during the consent dialogue - persons who are accomondated in an institution because of court injunction
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E.5 End points |
E.5.1 | Primary end point(s) |
Maximum decrease of GFR (absolute value in ml/min/1,73m² body surface) measured as difference between the preoperative initial value and the lowest value within the first days after partial nephrectomy |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after surgery, not later than the seventh postoperative day |
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E.5.2 | Secondary end point(s) |
- demographic data: age, height, BMI - data of anaesthesia: opiate consumption and insp. oxygen concentration during anaesthesia - direct time of tumour resection - duration of anaesthetics-exposition prior and after direct time of tumour resection and thus time of ischemia - tumour size and histology - activation of HIF-1α in healthy tissy of resection margin - appearance of macrophage migration-inhibiting factor (MIF) in serum - course of GFR, determined by Cystatin C-value in Serum until discarge, not later than 7 days postoperative - coursed of Serum-Creatinin until discarge, not later than 7 days postoperative - urinary excretion during intervention and within the first 48 h postoperative - appearance of acute kidney injury according to AKIN-Classifikation - appearance of AEs and SAEs
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- during surgery - after surgery, not later than the seventh postoperative day - urinary excretion during 48h after surgery |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |