Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

April 6, 2015 updated by: Eva M. Base, Medical University of Vienna

Phase 4 Study Comparing Albumin 5%, Hydroxyethylstrach 130/0.4 (6%) and Ringer Lactate for Volume Replacement During Cardiac Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Vienna General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Valve replacement
  • Coronary bypass surgery

Exclusion Criteria:

  • Severe left ventricular dysfunction
  • Coagulation disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hydroxyethylstarch
Drug: volume replacement
Hydroxyethylstarch up to 50mL/kg/24 hrs
Other Names:
  • Voluven
  • HES 130/0.4
Drug: volume replacement
up 10 50mL/kg/24 hours
Active Comparator: Humanalbumin
Drug: Humanalbumin 5%
Humanalbumin 5% up to 50 mL/kg/24 hours
Other Names:
  • Humanalbumin 5% Baxter
Active Comparator: Ringer lactate
Drug: volume replacement
Hydroxyethylstarch up to 50mL/kg/24 hrs
Other Names:
  • Voluven
  • HES 130/0.4
Drug: volume replacement
up 10 50mL/kg/24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
chest tube drainage
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin concentration
Time Frame: induction of anesthesia = baseline
induction of anesthesia = baseline
Hematocrit value
Time Frame: induction of anesthesia = baseline
induction of anesthesia = baseline
platelet count
Time Frame: induction of anesthesia = baseline
induction of anesthesia = baseline
activated clotting time
Time Frame: induction of anesthesia = baseline
induction of anesthesia = baseline
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
Time Frame: induction of anethesia = baseline
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
induction of anethesia = baseline
Hemoglobin concentration
Time Frame: average 1 hour on cardiopulmonary bypass
average 1 hour on cardiopulmonary bypass
Hematocrit value
Time Frame: average 1 hour on cardiopulmonary bypass
average 1 hour on cardiopulmonary bypass
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
Time Frame: average 1 hour on cardiopulmonary bypass
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
average 1 hour on cardiopulmonary bypass
activated clotting time
Time Frame: average 1 hour on cardiopulmonary bypass
average 1 hour on cardiopulmonary bypass
Hemoglobin concentration
Time Frame: 30 minutes after arrival ICU
30 minutes after arrival ICU
Hematocrit value
Time Frame: 30 minutes after arrival ICU
30 minutes after arrival ICU
platelet count
Time Frame: 30 minutes after arrival ICU
30 minutes after arrival ICU
activated clotting time
Time Frame: 30 minutes after arrival ICU
30 minutes after arrival ICU
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
Time Frame: 30 minutes after arrival ICU
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
30 minutes after arrival ICU
Hemoglobin concentration
Time Frame: 24 hours after surgery
24 hours after surgery
Hematocrit value
Time Frame: 24 hours after surgery
24 hours after surgery
platelet count
Time Frame: 24 hrs after surgery
24 hrs after surgery
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
Time Frame: 24 hrs after surgery
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
24 hrs after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Eva M Base, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 4, 2010

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAHes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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