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

This study has been terminated.
(organizational reasons at sites: low recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936247
First Posted: July 9, 2009
Last Update Posted: September 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
B. Braun Melsungen AG
  Purpose
This investigational study will investigate two different volume replacement regimes in patients suffering from compromised renal function.

Condition Intervention Phase
Renal Insufficiency Drug: HES 130/0.42 + electrolyte solution Drug: Albumin + electrolyte solution Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • Impact of two different volume replacement regimes on base excess in patients with reduced renal function [ Time Frame: from pre-operative assessment until last evaluation of data i.e. 5th (hospital) and 60th postoperative day (follow-up) ]

Secondary Outcome Measures:
  • Renal function, hemodynamics, blood loss, amount of given blood products, electrolytes, outcome and other data like concomitant medication [ Time Frame: inta-/postoperative ]

Enrollment: 2
Study Start Date: November 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936247


Locations
Germany
Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum der Stadt Ludwigshafen
Ludwigshafen, Germany, 67064
Klinikum Mannheim gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin
Mannheim, Germany, 68167
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
Principal Investigator: Thomas Lücke, Prof. Dr. Klinikum Mannheim gGmbH, Klink für Anästhesiologie und Operative Intensivmedizin
  More Information

Responsible Party: Dr. Simone Arnold, B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT00936247     History of Changes
Other Study ID Numbers: HC-G-H-0514
First Submitted: July 8, 2009
First Posted: July 9, 2009
Last Update Posted: September 28, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pharmaceutical Solutions