Valvular Heart DiseasePhase 4NCT01174719
Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery
A Phase 4 study testing volume replacement and Humanalbumin 5% in people with Valvular Heart Disease and Coronary Artery Disease, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Valvular Heart Disease, Coronary Artery Disease
- What is being tested?
- volume replacement and Humanalbumin 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2006to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Valve replacement
- Coronary bypass surgery
Who cannot join
- Severe left ventricular dysfunction
- Coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Valvular Heart Disease, Coronary Artery Disease
- Being tested
- volume replacement, Humanalbumin 5%
- Keywords
- Hydroxyethylstarch, Humanalbumin, Ringer Lactate, patients undergoing cardiac surgery
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume replacementDrug
Also called Voluven, HES 130/0.4
Hydroxyethylstarch up to 50mL/kg/24 hrs
Humanalbumin 5%Drug
Also called Humanalbumin 5% Baxter
Humanalbumin 5% up to 50 mL/kg/24 hours
volume replacementDrug
up 10 50mL/kg/24 hours
| Study group | Role | What they receive |
|---|---|---|
| Hydroxyethylstarch | Active comparator | Not described Receives: Drug: volume replacement |
| Humanalbumin | Active comparator | Not described Receives: Drug: Humanalbumin 5% |
| Ringer lactate | Active comparator | Not described Receives: Drug: volume replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
chest tube drainage
Measured: 24 hours
Secondary outcomes (18)
Hemoglobin concentration
Measured: induction of anesthesia = baseline
Hematocrit value
Measured: induction of anesthesia = baseline
platelet count
Measured: induction of anesthesia = baseline
activated clotting time
Measured: induction of anesthesia = baseline
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
Measured: induction of anethesia = baseline
Hemoglobin concentration
Measured: average 1 hour on cardiopulmonary bypass
Hematocrit value
Measured: average 1 hour on cardiopulmonary bypass
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
Measured: average 1 hour on cardiopulmonary bypass
activated clotting time
Measured: average 1 hour on cardiopulmonary bypass
Hemoglobin concentration
Measured: 30 minutes after arrival ICU
Hematocrit value
Measured: 30 minutes after arrival ICU
platelet count
Measured: 30 minutes after arrival ICU
activated clotting time
Measured: 30 minutes after arrival ICU
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
Measured: 30 minutes after arrival ICU
Hemoglobin concentration
Measured: 24 hours after surgery
Hematocrit value
Measured: 24 hours after surgery
platelet count
Measured: 24 hrs after surgery
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
using 3 activators: intrinsic ROTEM (InTEM, extrinsic ROTEM (ExTEM), finbrinogen ROTEM (FibTEM)
Measured: 24 hrs after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startMar 2006
- Primary completionFeb 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva M. Base, Medical University of Vienna
- Investigators
- Eva M Base, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174719
- Sponsor's protocol ID
- HAHes
- Status last verified
- Apr 2015
- First submitted
- 2 Aug 2010
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study Comparing Albumin 5%, Hydroxyethylstrach 130/0.4 (6%) and Ringer Lactate for Volume Replacement During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01174719
- Acronym / sponsor ID
- HAHes
- Conditions
- Valvular Heart Disease, Coronary Artery Disease
- Keywords
- Hydroxyethylstarch, Humanalbumin, Ringer Lactate, patients undergoing cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydroxyethylstarch | Active comparator | Drug: volume replacement |
| Humanalbumin | Active comparator | Drug: Humanalbumin 5% |
| Ringer lactate | Active comparator | Drug: volume replacement |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Valve replacement
- Coronary bypass surgery
Key exclusion criteria (2 listed)
- Severe left ventricular dysfunction
- Coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| volume replacementAlso: Voluven, HES 130/0.4Hydroxyethylstarch up to 50mL/kg/24 hrs | Drug | Hydroxyethylstarch |
| Humanalbumin 5%Also: Humanalbumin 5% BaxterHumanalbumin 5% up to 50 mL/kg/24 hours | Drug | Humanalbumin |
| volume replacementup 10 50mL/kg/24 hours | Drug | Ringer lactate |
Primary outcome
chest tube drainage
Time frame: 24 hours
18 secondary outcomes
Hemoglobin concentration
Time frame: induction of anesthesia = baseline
Hematocrit value
Time frame: induction of anesthesia = baseline
platelet count
Time frame: induction of anesthesia = baseline
activated clotting time
Time frame: induction of anesthesia = baseline
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
Time frame: induction of anethesia = baseline
Hemoglobin concentration
Time frame: average 1 hour on cardiopulmonary bypass
Hematocrit value
Time frame: average 1 hour on cardiopulmonary bypass
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
Time frame: average 1 hour on cardiopulmonary bypass
activated clotting time
Time frame: average 1 hour on cardiopulmonary bypass
Hemoglobin concentration
Time frame: 30 minutes after arrival ICU
Hematocrit value
Time frame: 30 minutes after arrival ICU
platelet count
Time frame: 30 minutes after arrival ICU
activated clotting time
Time frame: 30 minutes after arrival ICU
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
Time frame: 30 minutes after arrival ICU
Hemoglobin concentration
Time frame: 24 hours after surgery
Hematocrit value
Time frame: 24 hours after surgery
platelet count
Time frame: 24 hrs after surgery
Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)
Time frame: 24 hrs after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva M Base, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing volume replacement and Humanalbumin 5% in people with Valvular Heart Disease and Coronary Artery Disease, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chest tube drainage (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.