Back to results

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

Primary Purpose

Renal Insufficiency

Status

Terminated

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

HES 130/0.42 + electrolyte solution

Albumin + electrolyte solution

About this trial

This is an interventional treatment trial for Renal Insufficiency

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum der Stadt Ludwigshafen
Klinikum Mannheim gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

HES 130/0.42 + Sterofundin ISO

Albumin + NaCl 0.9%

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00936247

First Posted

July 8, 2009

Last Updated

September 27, 2010

Sponsor

B. Braun Melsungen AG

1. Study Identification

Unique Protocol Identification Number

NCT00936247

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Terminated

Why Stopped

organizational reasons at sites: low recruitment

Study Start Date

November 2009 (undefined)

Primary Completion Date

September 2010 (Anticipated)

Study Completion Date

September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

B. Braun Melsungen AG

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

HES 130/0.42 + Sterofundin ISO

Arm Title

Arm Type

Active Comparator

Arm Description

Albumin + NaCl 0.9%

Intervention Type

Drug

Intervention Name(s)

HES 130/0.42 + electrolyte solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Albumin + electrolyte solution

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Time Frame

inta-/postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Lücke, Prof. Dr.

Organizational Affiliation

Klinikum Mannheim gGmbH, Klink für Anästhesiologie und Operative Intensivmedizin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik für Anästhesiologie und operative Intensivmedizin, Klinikum der Stadt Ludwigshafen

City

Ludwigshafen

ZIP/Postal Code

67064

Country

Germany

Facility Name

Klinikum Mannheim gGmbH, Klinik für Anästhesiologie und Operative Intensivmedizin

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs