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Clinical Trials/NCT01174719
NCT01174719
Completed
Phase 4

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

Medical University of Vienna1 site in 1 country240 target enrollmentMarch 2006
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ConditionsValvular Heart DiseaseCoronary Artery Disease
Interventionsvolume replacementHumanalbumin 5%
Drugsvolume replacementHumanalbumin 5%

Overview

Phase
Phase 4
Intervention
volume replacement
Conditions
Valvular Heart Disease
Sponsor
Medical University of Vienna
Enrollment
240
Locations
1
Primary Endpoint
chest tube drainage
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2006
End Date
April 2010
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eva M. Base

Associate Professor

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • •Valve replacement
  • •Coronary bypass surgery

Exclusion Criteria

  • •Severe left ventricular dysfunction
  • •Coagulation disorders

Arms & Interventions

Ringer lactate

Intervention: volume replacement

Humanalbumin

Intervention: Humanalbumin 5%

Hydroxyethylstarch

Intervention: volume replacement

Outcomes

Primary Outcomes

chest tube drainage

Time Frame: 24 hours

Secondary Outcomes

  • Hemoglobin concentration(24 hours after surgery)
  • platelet count(24 hrs after surgery)
  • Hematocrit value(24 hours after surgery)
  • activated clotting time(30 minutes after arrival ICU)
  • Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)(24 hrs after surgery)

Study Sites (1)

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