E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing laparoscopic nefrectomy in generel anesthesia
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Patienter, der undergår laparoskopisk nefrektomi i generel anæstesi |
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E.1.1.1 | Medical condition in easily understood language |
Patients undergoing kidney removal by keyhole surgery under anesthesia
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Patienter, der får fjernet en nyre med kikkertoperation i fuld bedøvelse |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 | 10037775 |
E.1.2 | Term | Radical nephrectomy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
The objective is for elective laparoscopic nephrectomy to measure the effect of hydroxyethyl starch on biomarkers of nephrotoxicity (U-Alb, u- NGAL, u-Kim 1, u-FABP)
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Formålet er i forbindelse med elektiv laparoskopisk nefrektomi at måle effekten af hydroxyethylstivelse på biomarkører for nefrotoksicitet (u-Alb, u-N-GAL, u-Kim 1, u- FABP)
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E.2.2 | Secondary objectives of the trial |
Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water (FENa, u-ENaCβ, CH2O, u-AQP2, u-NCC, u-NK2CC), vasoactive hormones (PRC, p-Ang-II, p -Aldo, p-ANP, P-GDP, p-AVP, p-Endot) and central hemodynamics (SBP, DBP, heart rate) during elective laparoscopic nephrectomy
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Sekundært for at måle effekten af hydroxyethylstivelse på den renale tubulære transport af natrium og vand (FENa, u-ENaCβ, CH2O, u-AQP2, u-NCC, u-NK2CC), vasoaktive hormoner (PRC, p-Ang-II, p-Aldo, p-ANP, p-BNP, p-AVP, p-Endot) og central hæmodynamik (SBP, DBP, hjertefrekvens) i forbindelse med elektiv laparoskopisk nefrektomi
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age > 18 years
- Males and females
- Indication for laparoscopic nephrectomy OR
- Indiction for laparoscopic partial removal of the kidney OR
- Indication for laparoscopic glandel stageing
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- Alder > 18
- Mænd og kvinder
- Indikation for laparoskopisk nefrektomi ELLER
- Indikation for laparoskopisk partiel fjernelseaf nyren ELLER
- Indikation for laparoskopisk glandel stageing |
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E.4 | Principal exclusion criteria |
- Blooddonation within the last month
- Lack of wish to participate
- eGFR< 15ml/min
- pregnancy or breast feeding |
- Bloddonation inden for en måned inden operationen.
- Manglende lyst til at deltage
- eGFR < 15 ml/min
- graviditet eller amning |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.2 | Secondary end point(s) |
PRC, p-Ang-II, p-Aldo, p-ANP, p-BNP, p-AVP, p-Endot, CH2O, u-AQP2, FENa u- EnaCβ, u-Alb, u-Kim 1, u-FABP, u-NCC, u-NK2CC, heart rate, SBP and DBP |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | Yes |
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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Last visit of the last subject |
Sidste besøg af den sidste forsøgsperson |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |