Heart; Dysfunction Postoperative, Cardiac SurgeryPhase 4NCT01553617
VolulyteTM in Cardiac Surgery
A Phase 4 study testing 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) and Human serum albumin in people with Heart; Dysfunction Postoperative, Cardiac Surgery, run by Fresenius Kabi at 5 sites in Canada.
Trial summary
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Dysfunction Postoperative, Cardiac Surgery
- What is being tested?
- 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) and Human serum albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 5 sitesCanada
- Study dates
- Oct 2012to Jan 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female adult patients
- undergoing primary elective cardiac surgery applying extracorporeal circulation
- signed written informed consent
Who cannot join
- known contraindication against scheduled medication
- pre-operative acute normovolaemic haemodilution or preoperative autologous blood donation
- planned systemic hypothermia (body temperature < 30°C)
- expected time on ECC ≥ 2 hours
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
London Health Sciences Centre
London, Ontario
St. Michael's Hospital
Toronto, Ontario
Toronto General Hospital
Toronto, Ontario
Vancouver General Hospital
Vancouver, British Columbia
About this study
Official title: Efficacy and Safety of Perioperative Infusion of 6 % Hydroxyethyl Starch 130/0.4 in an Isotonic Electrolyte Solution (VolulyteTM) vs. 5% HSA as Volume Replacement Therapy During Cardiac Surgery for Adult Patients
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
- Being tested
- 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM), Human serum albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)Drug
Study drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day
Human serum albuminDrug
Control drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day
| Study group | Role | What they receive |
|---|---|---|
| Volulyte | Experimental | 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) Receives: Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) |
| Human serum albumin | Active comparator | Human serum albumin (HSA 50g/L) Receives: Drug: Human serum albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculated red blood cell loss
Measured: up to 3rd postoperative day
Secondary outcomes (5)
Haemodynamics
Measured: up to 3rd postoperative day
Fluid input/output
Quantity of total fluids administered and excreted or lost from beginning of anaesthesia until 3rd postoperative day
Measured: up to 3rd postoperative day
Use of vasoactive and inotropic drugs
Type and amount of vasoactive and inotropic drugs administered from beginning of anaesthesia until 3rd postoperative day
Measured: up to 3rd postoperative day
Laboratory parameters
Serum creatinine concentration at day 28 after surgery
Measured: up to day 28 after surgery
Laboratory parameters
set of standard laboratoy parameters before surgery and postoperatively until 3rd postop day
Measured: up to 3rd postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart; Dysfunction Postoperative, Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David C Mazer, Principal investigator, St. Michael's Hospital, Department of Anaesthesia, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553617
- Sponsor's protocol ID
- VOLU-010-C P4
- Status last verified
- Jun 2014
- First submitted
- 7 Mar 2012
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Perioperative Infusion of 6 % Hydroxyethyl Starch 130/0.4 in an Isotonic Electrolyte Solution (VolulyteTM) vs. 5% HSA as Volume Replacement Therapy During Cardiac Surgery for Adult Patients
- ClinicalTrials.gov ID
- NCT01553617
- Acronym / sponsor ID
- VOLU-010-C P4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Mar 2012 (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 study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volulyte | Experimental | Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) |
| Human serum albumin | Active comparator | Drug: Human serum albuminHuman serum albumin (HSA 50g/L) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female adult patients
- undergoing primary elective cardiac surgery applying extracorporeal circulation
- signed written informed consent
Key exclusion criteria (4 listed)
- known contraindication against scheduled medication
- pre-operative acute normovolaemic haemodilution or preoperative autologous blood donation
- planned systemic hypothermia (body temperature < 30°C)
- expected time on ECC ≥ 2 hours
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 |
|---|---|---|
| 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)Study drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day | Drug | Volulyte |
| Human serum albuminControl drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day | Drug | Human serum albumin |
Primary outcome
Calculated red blood cell loss
Time frame: up to 3rd postoperative day
5 secondary outcomes
Haemodynamics
Time frame: up to 3rd postoperative day
Fluid input/output
Time frame: up to 3rd postoperative day
Use of vasoactive and inotropic drugs
Time frame: up to 3rd postoperative day
Laboratory parameters
Time frame: up to day 28 after surgery
Laboratory parameters
Time frame: up to 3rd postoperative day
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 26 Jun 2014.
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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.
David C Mazer principal investigator
St. Michael's Hospital, Department of Anaesthesia, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) and Human serum albumin in people with Heart; Dysfunction Postoperative, Cardiac Surgery, run by Fresenius Kabi at 5 sites in Canada.
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 3 inclusion and 4 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 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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?
Calculated red blood cell loss (time frame: up to 3rd postoperative day). 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 26 Jun 2014.