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

NCT ID: NCT00936247

Last Updated: 2010-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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Conditions

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Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

HES 130/0.42 + Sterofundin ISO

Group Type EXPERIMENTAL

HES 130/0.42 + electrolyte solution

Intervention Type DRUG

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

2

Albumin + NaCl 0.9%

Group Type ACTIVE_COMPARATOR

Albumin + electrolyte solution

Intervention Type DRUG

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

Interventions

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HES 130/0.42 + electrolyte solution

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

Intervention Type DRUG

Albumin + electrolyte solution

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

Intervention Type DRUG

Eligibility Criteria

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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:

* 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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B. Braun Melsungen AG

INDUSTRY

Sponsor Role lead

Responsible Party

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B. Braun Melsungen AG

Principal Investigators

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Thomas Lücke, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Mannheim gGmbH, Klink für Anästhesiologie und Operative Intensivmedizin

Locations

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Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum der Stadt Ludwigshafen

Ludwigshafen, , Germany

Site Status

Klinikum Mannheim gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin

Mannheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HC-G-H-0514

Identifier Type: -

Identifier Source: org_study_id