The goal of the study is to improve the patients prognostif by decreasing perioperative blood losses thanks to two new colloidal solutions (last generation starches extracted from corn or potato) and thanks to an optimisation of the vascular filling by a low invasive monitoring: the vigileo.
- Conditions
- Elective cardiac surgeryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2011-005920-16-BE
- Lead Sponsor
- Association Hospitalière CHU Brugmann
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Patients over the age of 18 years
- Patients with an elective cardiac surgery, except emergency
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 81
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37
- Patients with an ASA class >3
- Cardiac decompression (HYHA class > III)
- Cardiac aryhtmies
- Significant aortic regurgitation
- Coagulation alteration: platelet count <100000; INR>1,5 ; TCA > normal values)
- Pre-existing renal insufficience (seric creatinin > 2 mg/ml) or oligo-anury, or hemodyalised patient
- Hepatic function alteration (AST and ALT > two times the normal value)
- Pregnancy
- Surgical emergency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Security of hydroxyethyl starches;Secondary Objective: Security and efficacy of hydroxyethyl starches;Primary end point(s): Measure and calculation of blood losses;Timepoint(s) of evaluation of this end point: 48 h
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Creatinine clearance measure<br>- Fluid balance measure<br>- Volemic expansion measure<br>- Other measures: gazometry, ionomerty, renal function, hemostasis, need of blood products, length of stay in intensive care, hospitalisation length, eventual side effects.;Timepoint(s) of evaluation of this end point: 48 h