renal function after partial nephrectomy MedDRA version: 14.1 Level: LLT Classification code 10034072 Term: Partial nephrectomy System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Forene
Product Name: Forene
Pharmaceutical Form: Inhalation solution
Trade Name: Lenoxe
Pharmaceutical Form: Inhalation solution
Sponsors
Clinical Trial Center Aachen
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - renal failure with a glomerular filtration rate 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate, if an anaesthesia conducted with xenon has a positive influence of the postoperative renal function;Secondary Objective: not applicable;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;Timepoint(s) of evaluation of this end point: after surgery, not later than the seventh postoperative day | — |
Secondary
| Measure | Time frame |
|---|---|
| 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-1a 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 ;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 | — |
Countries
Germany
Contacts
Public ContactAngela Sudhoff
Clinical Trial Center Aachen
Outcome results
None listed