Cardiac SurgeryPhase 2/3NCT00337805
Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery
A Phase 2/3 study testing Pentaspan in people with Cardiac Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
This is a randomized double blind trial of the use of the use of colloids vs crystalloid solutions for resuscitation of patients after cardiac surgery. Patients are managed with an algorithm driven protocol that is based on the flow response to fluid challenges. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Pentaspan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to Apr 2008
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- status post cardiac surgery
- pulmonary artery occlusion catheter in place
- informed consent
- morning case (must be out of OR by 2:00 PM
Who cannot join
- excessive bleeding (> 200 cc/hr)
- intraaortic balloon pump
- refusal by treating team
- emergency cases
- patients with known adverse reactions to starch solutions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Synthetic vs Normal Saline for the Flow-based Algorithmic Hemodynamic Resuscitation of Patients Post-cardiac Surgery
This is a randomized double blind trial of the use of the use of colloids vs crystalloid solutions for resuscitation of patients after cardiac surgery. Patients are managed with an algorithm driven protocol that is based on the flow response to fluid challenges. The hypothesis is that the use of a colloid solution will result in less use of catecholamines at 8:00 the morning following surgery. Secondary end-points include total use of catecholamines, time in the ICU, return to the ICU, and safety issues including bleeding and renal function.
- Conditions
- Cardiac Surgery
- Being tested
- Pentaspan
- Keywords
- colloid, crystalloid, hemodynamics, flow-directed, resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentaspanOther
When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment
| Study group | Role | What they receive |
|---|---|---|
| 1 colloid | Active comparator | Boluses of fluids are a pentastarch (up to 1000 ml) Receives: Other: Pentaspan |
| 2. Crytalloid | Active comparator | Boluses are given as normal saline Receives: Other: Pentaspan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of catecholamines at 8:00 the morning after surgery
Measured: first post operative day
Secondary outcomes (5)
Total use of catecholamines
Measured: Time in ICU
Time in the ICU
Measured: Time in ICU
Post-operative complications
Measured: Hospital stay or 28 days
Bleeding
Measured: Hospital stay or 28 days
Renal failure
Measured: Hospital stay or 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startSep 2004
- Primary completionDec 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- sheldon magder, md, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337805
- Sponsor's protocol ID
- BMA-04-016
- Status last verified
- Sep 2009
- First submitted
- 14 Jun 2006
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Potter BJ, Deverenne B, Doucette S, Fergusson D, Magder S; Canadian Critical Care Trials Group. Cardiac output responses in a flow-driven protocol of resuscitation following cardiac surgery. J Crit Care. 2013 Jun;28(3):265-9. doi: 10.1016/j.jcrc.2012.09.008. Epub 2012 Nov 14.
PubMed 23159133
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Synthetic vs Normal Saline for the Flow-based Algorithmic Hemodynamic Resuscitation of Patients Post-cardiac Surgery
- ClinicalTrials.gov ID
- NCT00337805
- Acronym / sponsor ID
- BMA-04-016
- Conditions
- Cardiac Surgery
- Keywords
- colloid, crystalloid, hemodynamics, flow-directed, resuscitation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 16 Jun 2006 (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.
This is a randomized double blind trial of the use of the use of colloids vs crystalloid solutions for resuscitation of patients after cardiac surgery. Patients are managed with an algorithm driven protocol that is based on the flow response to fluid challenges. The hypothesis is that the use of a colloid solution will result in less use of catecholamines at 8:00 the morning following surgery. Secondary end-points include total use of catecholamines, time in the ICU, return to the ICU, and safety issues including bleeding and renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 colloid | Active comparator | Other: PentaspanBoluses of fluids are a pentastarch (up to 1000 ml) |
| 2. Crytalloid | Active comparator | Other: PentaspanBoluses are given as normal saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- status post cardiac surgery
- pulmonary artery occlusion catheter in place
- informed consent
- morning case (must be out of OR by 2:00 PM
Key exclusion criteria (5 listed)
- excessive bleeding (> 200 cc/hr)
- intraaortic balloon pump
- refusal by treating team
- emergency cases
- patients with known adverse reactions to starch solutions
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 |
|---|---|---|
| PentaspanWhen fluids are indicated either pentaspan or saline are given in a double blind randomized assignment | Other | 1 colloid, 2. Crytalloid |
Primary outcome
Use of catecholamines at 8:00 the morning after surgery
Time frame: first post operative day
5 secondary outcomes
Total use of catecholamines
Time frame: Time in ICU
Time in the ICU
Time frame: Time in ICU
Post-operative complications
Time frame: Hospital stay or 28 days
Bleeding
Time frame: Hospital stay or 28 days
Renal failure
Time frame: Hospital stay or 28 days
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 18 Sep 2009.
- Derived from this study: PubMed 23159133Potter BJ, Deverenne B, Doucette S, Fergusson D, Magder S; Canadian Critical Care Trials Group. Cardiac output responses in a flow-driven protocol of resuscitation following cardiac surgery. J Crit Care. 2013 Jun;28(3):265-9. doi: 10.1016/j.jcrc.2012.09.008. Epub 2012 Nov 14.
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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.
sheldon magder, md principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pentaspan in people with Cardiac Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site 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 4 inclusion and 5 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 18 Sep 2009. 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 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Use of catecholamines at 8:00 the morning after surgery (time frame: first post operative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00337805, which also lists 1 linked publication.
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 18 Sep 2009.