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

NCT00936247 | Terminated Phase 4

• 1 other identifier: HC-G-H-0514
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• Impact of two different volume replacement regimes on base excess in patients with reduced renal function

  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

  inta-/postoperative

Study Arms (2)

1

EXPERIMENTAL

HES 130/0.42 + Sterofundin ISO

Drug: HES 130/0.42 + electrolyte solution

2

ACTIVE COMPARATOR

Albumin + NaCl 0.9%

Drug: Albumin + electrolyte solution

Interventions

HES 130/0.42 + electrolyte solution DRUG

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

1

Albumin + electrolyte solution DRUG

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

2

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (2)

Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum der Stadt Ludwigshafen

Ludwigshafen, 67064, Germany

Location

Klinikum Mannheim gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin

Mannheim, 68167, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Albumins

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Thomas Lücke, Prof. Dr.

  Klinikum Mannheim gGmbH, Klink für Anästhesiologie und Operative Intensivmedizin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 28, 2010

Record last verified: 2010-09

Locations

DE (2)