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:
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT00936247
First received: July 8, 2009
Last updated: September 27, 2010
Last verified: September 2010
  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 Blind (Subject)
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) ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Simone Arnold, B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT00936247     History of Changes
Other Study ID Numbers: HC-G-H-0514
Study First Received: July 8, 2009
Last Updated: September 27, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Citric Acid
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014