Humanalbumin, Hydroxyethylstarch and Ringer Lactate Durin... | NCT01174719

Studies
Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

NCT01174719

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Apr 8, 2015Estimated

Enrollment

240Actual

Phase

Phase 4

Conditions

Valvular Heart Disease
Coronary Artery Disease

Interventions

volume replacement
Humanalbumin 5%
volume replacement

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Feb 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Aug 2, 2010

First Submission Date that Met QC Criteria

Aug 3, 2010

First Posted Date

Aug 4, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2015

Last Update Posted Date

Apr 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Hydroxyethylstarch	Active Comparator	Drug: volume replacement
Humanalbumin	Active Comparator	Drug: Humanalbumin 5%
Ringer lactate	Active Comparator	Drug: volume replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
volume replacement	Drug	Hydroxyethylstarch up to 50mL/kg/24 hrs	Hydroxyethylstarch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
chest tube drainage		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Hemoglobin concentration		induction of anesthesia = baseline
Hematocrit value		induction of anesthesia = baseline
platelet count

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Valve replacement
Coronary bypass surgery

Exclusion Criteria:

Severe left ventricular dysfunction
Coagulation disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva M Base, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vienna General Hospital		Vienna	State of Vienna	1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D006349	Heart Valve Diseases
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C485123	HES 130-0.4
D006895	Hydroxyethyl Starch Derivatives

Ancestor Terms

ID	Term
D013213	Starch
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005936	Glucans

Browse Leaves

Not provided

Browse Branches

Not provided