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Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

Primary Purpose

Valvular Heart Disease, Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
volume replacement
Humanalbumin 5%
volume replacement
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Valvular Heart Disease focused on measuring Hydroxyethylstarch, Humanalbumin, Ringer Lactate, patients undergoing cardiac surgery

Eligibility Criteria

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

Inclusion Criteria:

  • Valve replacement
  • Coronary bypass surgery

Exclusion Criteria:

  • Severe left ventricular dysfunction
  • Coagulation disorders

Sites / Locations

  • Vienna General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Hydroxyethylstarch

Humanalbumin

Ringer lactate

Arm Description

Outcomes

Primary Outcome Measures

chest tube drainage

Secondary Outcome Measures

Hemoglobin concentration
Hematocrit value
platelet count
activated clotting time
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
Hemoglobin concentration
Hematocrit value
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
activated clotting time
Hemoglobin concentration
Hematocrit value
platelet count
activated clotting time
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
Hemoglobin concentration
Hematocrit value
platelet count
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)

Full Information

First Posted
August 2, 2010
Last Updated
April 6, 2015
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01174719
Brief Title
Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery
Official Title
Phase 4 Study Comparing Albumin 5%, Hydroxyethylstrach 130/0.4 (6%) and Ringer Lactate for Volume Replacement During Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to compare three different regimens for volume replacement during cardiac surgery, e.g. Albumin 5%, Hydroxyethylstarch 130/0.4 (HES) and Ringer-Lactate (RL). Main Outcome parameters: chest tube drainage and coagulation parameters. The investigators hypothesis is that HES is as safe as Albumin, however less expensive. Whether RL is an even less expensive and as safe alternative has to be shown.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease, Coronary Artery Disease
Keywords
Hydroxyethylstarch, Humanalbumin, Ringer Lactate, patients undergoing cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydroxyethylstarch
Arm Type
Active Comparator
Arm Title
Humanalbumin
Arm Type
Active Comparator
Arm Title
Ringer lactate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
volume replacement
Other Intervention Name(s)
Voluven, HES 130/0.4
Intervention Description
Hydroxyethylstarch up to 50mL/kg/24 hrs
Intervention Type
Drug
Intervention Name(s)
Humanalbumin 5%
Other Intervention Name(s)
Humanalbumin 5% Baxter
Intervention Description
Humanalbumin 5% up to 50 mL/kg/24 hours
Intervention Type
Drug
Intervention Name(s)
volume replacement
Intervention Description
up 10 50mL/kg/24 hours
Primary Outcome Measure Information:
Title
chest tube drainage
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Hemoglobin concentration
Time Frame
induction of anesthesia = baseline
Title
Hematocrit value
Time Frame
induction of anesthesia = baseline
Title
platelet count
Time Frame
induction of anesthesia = baseline
Title
activated clotting time
Time Frame
induction of anesthesia = baseline
Title
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
Description
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
Time Frame
induction of anethesia = baseline
Title
Hemoglobin concentration
Time Frame
average 1 hour on cardiopulmonary bypass
Title
Hematocrit value
Time Frame
average 1 hour on cardiopulmonary bypass
Title
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
Description
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
Time Frame
average 1 hour on cardiopulmonary bypass
Title
activated clotting time
Time Frame
average 1 hour on cardiopulmonary bypass
Title
Hemoglobin concentration
Time Frame
30 minutes after arrival ICU
Title
Hematocrit value
Time Frame
30 minutes after arrival ICU
Title
platelet count
Time Frame
30 minutes after arrival ICU
Title
activated clotting time
Time Frame
30 minutes after arrival ICU
Title
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
Description
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
Time Frame
30 minutes after arrival ICU
Title
Hemoglobin concentration
Time Frame
24 hours after surgery
Title
Hematocrit value
Time Frame
24 hours after surgery
Title
platelet count
Time Frame
24 hrs after surgery
Title
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
Description
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
Time Frame
24 hrs after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Valve replacement Coronary bypass surgery Exclusion Criteria: Severe left ventricular dysfunction Coagulation disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva M Base, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna General Hospital
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

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