Tetraspan 6 Percent (%) Combined With Sterofundin ISO Versus Albumin 5 Percent (%) Combined With Sodium Chloride (NaCL)

Study Overview
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Brief Summary
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This investigational study will investigate two different volume replacement regimes in patients suffering from compromised renal function.

Official Title
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Prospective, Controlled, Single-blind, Bicentric, Randomized Study on the Safety of HES 130/0.42 Combined With a Bal. Electr. Sol. vs 5% Albumin Comb. With an Unbal. Electr. Sol. (NaCl 0.9%) in Pat. With Compensated Renal Failure

Conditions
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Renal Insufficiency

Intervention / Treatment
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* Drug: HES 130/0.42 + electrolyte solution
* Drug: Albumin + electrolyte solution


Participation Criteria
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Eligibility Criteria
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Inclusion: male or female patients ≥ 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; 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 Exclusion: patients of ASA-class > III; patients with daily urine output < 1 l; 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 function, congestive heart failure); simultaneous participation in another clinical trial; emergencies; patients scheduled for brain surgery; patients incapable to give informed consent (e.g. patients with dementia, psychiatric diseases or suffering from conditions associated with lack of consciousness)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>HES 130/0.42 + Sterofundin ISO | Drug: HES 130/0.42 + electrolyte solution<br>* Tetraspan 6% as colloid component combined with Sterofundin ISO as electrolyte component<br>|
| Active Comparator: 2<br>Albumin + NaCl 0.9% | Drug: Albumin + electrolyte solution<br>* Albumin 5% as colloid component and NaCl 0.9% as electrolyte component<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function, hemodynamics, blood loss, amount of given blood products, electrolytes, outcome and other data like concomitant medication |  | inta-/postoperative |