Prospective, controlled, single-blind, bicentric, randomized study on the safety of HES 130/0.42 combined with a balanced electrolyte solution vs. 5% Albumin combined with an unbalanced electrolyte solution (NaCl 0.9%) in patients with compensated renal failure

• Conditions: acid-base status intra- and postoperatively; MedDRA version: 9.1Level: PTClassification code 10000456Term: Acid base balance

• Registration Number: EUCTR2006-001879-38-DE
• Lead Sponsor: B. Braun Melsungen AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-16
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- Patients of ASA-class > III
- Patients with daily urine output < 1L
- Patients on haemodialysis
- Patients receiving HES during the last 48 hours before first infusion of the investigational products
- Patients suffering from coagulation disorders (i.e. PTT > 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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