E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Comparison of 6% Hydroxyethyl Starch and 5% Albumin for Volume Replacement Therapy in Patients Undergoing Cystectomy |
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E.1.1.1 | Medical condition in easily understood language |
Comparison of 6% Hydroxyethyl Starch and 5% Albumin for Volume Replacement Therapy in Patients Elimination of the Bladder |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021139 |
E.1.2 | Term | Hypovolemia |
E.1.2 | System Organ Class | 100000004861 |
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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 compare the effects on renal function of Humanalbumin (HA) with those of Hydroxyethyl starch (HES) when administered for perioperative volume replacement in patients undergoing cystectomy aiming to demonstrate superiority of HA over HES. |
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E.2.2 | Secondary objectives of the trial |
To explore the influence of the HA vs. HES on other lab-chemical and clinical parameters, hospital and ICU stay, acute kidney injury, and pruritus. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients male or female, aged 18 to 85 years
• Patient undergoing cystectomy with urinary diversion by an ileum conduit or neobladder
• Ability to follow study instructions and likely to attend and complete all required visits
• Written informed consent |
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E.4 | Principal exclusion criteria |
• Unfavorable prognosis (e. g. palliative surgical care in cases of obstruction of the efferent urinary tract)
• Evidence for metastatic disease
• Coagulopathy or platelet dysfunction
• Preoperative creatinine clearance <30ml/min
• Preoperative chemotherapy with nephrotoxic drugs (e. g. Cisplatin)
• Application of more than 1000ml colloid solution within the last 24 hours before surgical intervention
• Physical or acute medical condition, psychiatric condition or laboratory abnormality which at the investigator’s discretion may put the patient at risk, may confound the trial results, or may interfere with the patient’s participation in this clinical trial
• History of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
• History of uncontrolled chronic disease or a concurrent clinically significant illness, medical condition, which in the investigator’s opinion, would contraindicate study participation or compliance with protocol mandated procedures
• Known or persistent abuse of medication, drugs or alcohol
• Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
Ratio of Cystatin C measured in serum at day 90 relative to the pre-operative value |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Incidence of acute kidney injury as defined by RIFLE criteria (in hos-pital and in mid-term (3 months))
• Relative change of calculated GFR (by Cystatin C) up to the third postoperative day
• Glykokalix shedding (syndecan-1, heparan sulfate, hyaluronan) at days 0, 1, and 3
• Glomerular damage (NGAL) at days 0, 1, 3 and 90
• Length of ICU and hospital stay
• Necessity and duration of renal replacement therapy
• Presence of pruritus at day 90
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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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The regular end of trial is defined as “Last Subject Last Visit”. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |