Tetraspan 6 Percent (%) Combined With Sterofundin ISO Versus Albumin 5 Percent (%) Combined With Sodium Chloride (NaCL)
Phase 4
Terminated
- Conditions
- Renal Insufficiency
- Interventions
- Drug: Albumin + electrolyte solution
- Registration Number
- NCT00936247
- Lead Sponsor
- B. Braun Melsungen AG
- Brief Summary
This investigational study will investigate two different volume replacement regimes in patients suffering from compromised renal function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 HES 130/0.42 + electrolyte solution HES 130/0.42 + Sterofundin ISO 2 Albumin + electrolyte solution Albumin + NaCl 0.9%
- Primary Outcome Measures
Name Time Method Impact of two different volume replacement regimes on base excess in patients with reduced renal function from pre-operative assessment until last evaluation of data i.e. 5th (hospital) and 60th postoperative day (follow-up)
- Secondary Outcome Measures
Name Time Method Renal function, hemodynamics, blood loss, amount of given blood products, electrolytes, outcome and other data like concomitant medication inta-/postoperative
Trial Locations
- Locations (2)
Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum der Stadt Ludwigshafen
🇩🇪Ludwigshafen, Germany
Klinikum Mannheim gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin
🇩🇪Mannheim, Germany