acid-base status intra- and postoperatively MedDRA version: 9.1 Level: PT Classification code 10000456 Term: Acid base balance
Conditions
Interventions
Trade Name: Tetraspan 6%
Pharmaceutical Form: Solution for infusion
Trade Name: Sterofundin ISO
Pharmaceutical Form: Solution for infusion
Trade Name: Human Albumin 50g/l Baxter
Pharmaceutical Form:
Sponsors
B. Braun Melsungen AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients older than 50 years of age - Patients with compromised renal function, i.e. serum creatinine between 1.5 mg/dl and 3.0 mg/dl - Patients scheduled for elective intervention - Patients with an estimated intraoperative volume need of at least 1 L colloids - Patients suffering from non-oliguric renal failure - Provision of voluntary informed consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients of ASA-class > III - Patients with daily urine output 60 sec) - Patients with a hemoglobin < 9 g/dl - Patients with known hypersensitivity to HES, albumin or any of the excipients - Patients suffering from contraindications of the investigational products (i.e. Hyperhydration state including pulmonary oedema, renal failure with oliguria or anuria, intracranial haemorrhage, hyperkalaemia, severe hypernatraemia or severe hyperchloraemia, severely impaired hepatic fuction, congestive heart failure) - Simultaneous participation in another clinical trial - Emergencies - Patients incapable to give informed consent (e. g. patients with dementia, psychiatric diseases or suffering from conditions associated with lack of conciousness)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Impact of two different volume replacement therapy regimes (Tetraspan 6% + Sterofundin ISO vs. Albumin + NaCl) on base excess in patients with reduced renal function (i.e. serum creatinine between 1.5 mg/dl and 3.0 mg/dl);Secondary Objective: Investigation of safety and efficacy of a balanced and an unbalanced volume replacement regime: Renal function, perioperative bleeding, amount of given blood products (RBC, platelets, FFP), concomitant medicaiton, hemodynamics;Primary end point(s): base excess | — |
Countries
Germany
Outcome results
None listed