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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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00936247
Enrollment
2
Registered
2009-07-09
Start date
2009-11-30
Completion date
2010-09-30
Last updated
2010-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency

Brief summary

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

Interventions

DRUGHES 130/0.42 + electrolyte solution

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

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

Sponsors

B. Braun Melsungen AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion 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)

Design outcomes

Primary

MeasureTime frame
Impact of two different volume replacement regimes on base excess in patients with reduced renal functionfrom pre-operative assessment until last evaluation of data i.e. 5th (hospital) and 60th postoperative day (follow-up)

Secondary

MeasureTime frame
Renal function, hemodynamics, blood loss, amount of given blood products, electrolytes, outcome and other data like concomitant medicationinta-/postoperative

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026