Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174719
• Other study ID #: HAHes
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2010
• Last updated: April 6, 2015
• Start date: March 2006
• Est. completion date: April 2010

Study information

• Verified date: April 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Valve replacement

• Coronary bypass surgery

Exclusion Criteria:

• Severe left ventricular dysfunction

• Coagulation disorders

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Valve Diseases
• Myocardial Ischemia
• Valvular Heart Disease

Intervention

Drug:
• volume replacement
Hydroxyethylstarch up to 50mL/kg/24 hrs
• Humanalbumin 5%
Humanalbumin 5% up to 50 mL/kg/24 hours
• volume replacement
up 10 50mL/kg/24 hours

Locations

Country	Name	City	State
Austria	Vienna General Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chest tube drainage		24 hours	Yes
Secondary	Hemoglobin concentration		induction of anesthesia = baseline	No
Secondary	Hematocrit value		induction of anesthesia = baseline	No
Secondary	platelet count		induction of anesthesia = baseline	No
Secondary	activated clotting time		induction of anesthesia = baseline	No
Secondary	Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)	using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)	induction of anethesia = baseline	No
Secondary	Hemoglobin concentration		average 1 hour on cardiopulmonary bypass	No
Secondary	Hematocrit value		average 1 hour on cardiopulmonary bypass	No
Secondary	Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)	using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)	average 1 hour on cardiopulmonary bypass	No
Secondary	activated clotting time		average 1 hour on cardiopulmonary bypass	No
Secondary	Hemoglobin concentration		30 minutes after arrival ICU	No
Secondary	Hematocrit value		30 minutes after arrival ICU	No
Secondary	platelet count		30 minutes after arrival ICU	No
Secondary	activated clotting time		30 minutes after arrival ICU	No
Secondary	Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)	using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)	30 minutes after arrival ICU	No
Secondary	Hemoglobin concentration		24 hours after surgery	No
Secondary	Hematocrit value		24 hours after surgery	No
Secondary	platelet count		24 hrs after surgery	No
Secondary	Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)	using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)	24 hrs after surgery	No