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

Renal Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00936247
• Other study ID #: HC-G-H-0514
• Status: Terminated
• Phase: Phase 4
• First received: July 8, 2009
• Last updated: September 27, 2010
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• HES 130/0.42 + electrolyte solution
Tetraspan 6% as colloid component combined with Sterofundin ISO as electrolyte component
• Albumin + electrolyte solution
Albumin 5% as colloid component and NaCl 0.9% as electrolyte component

Locations

Country	Name	City	State
Germany	Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum der Stadt Ludwigshafen	Ludwigshafen
Germany	Klinikum Mannheim gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Renal function, hemodynamics, blood loss, amount of given blood products, electrolytes, outcome and other data like concomitant medication		inta-/postoperative	Yes