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Status:

TERMINATED

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

Lead Sponsor:

B. Braun Melsungen AG

Conditions:

Renal Insufficiency

Eligibility:

All Genders

50-80 years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    November 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2010

    Estimated Enrollment :

    2 Patients enrolled

    Trial Details

    Trial ID

    NCT00936247

    Start Date

    November 1 2009

    End Date

    September 1 2010

    Last Update

    September 28 2010

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum der Stadt Ludwigshafen

    Ludwigshafen, Germany, 67064

    2

    Klinikum Mannheim gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin

    Mannheim, Germany, 68167