Clinical trial NCT00936247: Tetraspan 6 Percent (%) Combined With Sterofundin ISO Versus Albumin 5 Percent (%) Combined With Sodium Chloride (NaCL)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Renal Insufficiency
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 2
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This investigational study will investigate two different volume replacement regimes in patients suffering from compromised renal function.


Eligibility criteria: 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)

Primary outcomes:
measure: Impact of two different volume replacement regimes on base excess in patients with reduced renal function
timeFrame: from pre-operative assessment until last evaluation of data i.e. 5th (hospital) and 60th postoperative day (follow-up)
Secondary outcomes:
measure: Renal function, hemodynamics, blood loss, amount of given blood products, electrolytes, outcome and other data like concomitant medication
timeFrame: inta-/postoperative
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum der Stadt Ludwigshafen
city: Mannheim
country: Germany
facility: Klinikum Mannheim gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin
Study officials:
affiliation: Klinikum Mannheim gGmbH, Klink für Anästhesiologie und Operative Intensivmedizin
name: Thomas Lücke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: