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TerminatedNCT00936247Updated Sep 28, 2010

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

A Phase 4 interventional study of HES 130/0.42 + electrolyte solution and Albumin + electrolyte solution in Renal Insufficiency, sponsored by B. Braun Melsungen AG. Terminated at 2 sites in Germany. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-09-28.

Sponsored by B. Braun Melsungen AG · Phase 4, Interventional, and Treatment

Why this study was terminated
organizational reasons at sites: low recruitment
Phase
Phase 4
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Renal Insufficiency

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03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 2 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

B. Braun Melsungen AG is the lead sponsor of 46 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    1

    HES 130/0.42 + Sterofundin ISO

    Drug: HES 130/0.42 + electrolyte solution

  • Active comparator
    2

    Albumin + NaCl 0.9%

    Drug: Albumin + electrolyte solution

Interventions

  • DrugHES 130/0.42 + electrolyte solution

    Tetraspan 6% as colloid component combined with Sterofundin ISO as electrolyte component

  • DrugAlbumin + electrolyte solution

    Albumin 5% as colloid component and NaCl 0.9% as electrolyte component

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Renal function, hemodynamics, blood loss, amount of given blood products, electrolytes, outcome and other data like concomitant medication

    Time frame: inta-/postoperative

07

Study locations

2 sites
  • Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum der Stadt Ludwigshafen
    Ludwigshafen, 67064, Germany
  • Klinikum Mannheim gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin
    Mannheim, 68167, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00936247
Lead sponsor
B. Braun Melsungen AG
First posted
Jul 9, 2009
Start date
Nov 2009
Primary completion
Sep 2010 (estimated)
Completion
Sep 2010 (estimated)
Last update
Sep 28, 2010

Study contacts

Thomas Lücke, Prof. Dr.
principal investigator · Klinikum Mannheim gGmbH, Klink für Anästhesiologie und Operative Intensivmedizin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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