Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

NCT ID: NCT01174719

Last Updated: 2015-04-08

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Valvular Heart Disease Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Hydroxyethylstarch

Group Type ACTIVE_COMPARATOR

volume replacement

Intervention Type DRUG

Hydroxyethylstarch up to 50mL/kg/24 hrs

Humanalbumin

Group Type ACTIVE_COMPARATOR

Humanalbumin 5%

Intervention Type DRUG

Humanalbumin 5% up to 50 mL/kg/24 hours

Ringer lactate

Group Type ACTIVE_COMPARATOR

volume replacement

Intervention Type DRUG

up 10 50mL/kg/24 hours

Interventions

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volume replacement

Hydroxyethylstarch up to 50mL/kg/24 hrs

Intervention Type DRUG

Humanalbumin 5%

Humanalbumin 5% up to 50 mL/kg/24 hours

Intervention Type DRUG

volume replacement

up 10 50mL/kg/24 hours

Intervention Type DRUG

Other Intervention Names

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Voluven HES 130/0.4 Humanalbumin 5% Baxter

Eligibility Criteria

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Inclusion Criteria

* Valve replacement
* Coronary bypass surgery

Exclusion Criteria

* Severe left ventricular dysfunction
* Coagulation disorders
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Eva M. Base

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva M Base, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Vienna General Hospital

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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HAHes

Identifier Type: -

Identifier Source: org_study_id

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