Comparison of 6% Hydroxyethyl Starch and 5% Albumin for Volume Replacement Therapy in Patients Undergoing Cystectomy MedDRA version: 15.1 Level: LLT Classification code 10021139 Term: Hypovolemia System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Humanalbin
Pharmaceutical Form: Solution for infusion
Trade Name: Volulyte 6% Infusionsloesung
Pharmaceutical Form: Solution for infusion
Sponsors
Ludwigs Maximilians University
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Ratio of Cystatin C measured in serum at day 90 relative to the pre-operative value;Timepoint(s) of evaluation of this end point: day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;Timepoint(s) of evaluation of this end point: days 0, 1, 3 and 90 | — |
Countries
Germany
Contacts
Public ContactDepartment of Anaesthesiology
Ludwigs Maximilians University
Outcome results
None listed