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

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

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

Study Overview

• Status: Terminated
• Conditions: Renal Insufficiency
• Intervention / Treatment: Drug: HES 130/0.42 + electrolyte solution; Drug: Albumin + electrolyte solution

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Ludwigshafen, Germany, 67064
    • Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum der Stadt Ludwigshafen
  • Mannheim, Germany, 68167
    • Klinikum Mannheim gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Thomas Lücke, Prof. Dr., Klinikum Mannheim gGmbH, Klink für Anästhesiologie und Operative Intensivmedizin

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): September 1, 2010
• Study Completion (Anticipated): September 1, 2010

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (Estimate): July 9, 2009

Study Record Updates

• Last Update Posted (Estimate): September 28, 2010
• Last Update Submitted That Met QC Criteria: September 27, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Pharmaceutical Solutions
• Other Study ID Numbers: HC-G-H-0514