Coronary Artery Bypass SurgerySSACSNCT00964015
Starch or Saline After Cardiac Surgery
A study testing 6% Hydroxyethyl Starch 130/0.4 and 0.9% Normal Saline in people with Coronary Artery Bypass Surgery, run by London Health Sciences Centre at 1 site in Canada.
Trial summary
When people undergo major surgery, they require intravenous supplementation of fluids for a number of reasons: to compensate for no oral intake to support blood pressure and organ function during and after surgery to replace lost fluid or blood volume There are a variety of fluid choices doctors have to provide to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Surgery
- What is being tested?
- 6% Hydroxyethyl Starch 130/0.4 and 0.9% Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Jun 2012
- Phase
- Interventional
- 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
- patients undergoing elective primary isolated on-pump coronary artery bypass grafting
Who cannot join
- pregnant patients
- patients with an active intra-cranial bleed
- patients with a history of hypersensitivity to starch solutions
- patients with Stage 4 or 5 Kidney Disease (estimated glomerular filtration rate < 30 ml / min / 1.73 m2)
- patients with a significant preoperative metabolic acidosis, defined by a preoperative capillary blood pH less than or equal to 7.2 and a serum bicarbonate less than 15
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial
When people undergo major surgery, they require intravenous supplementation of fluids for a number of reasons:
- to compensate for no oral intake
- to support blood pressure and organ function during and after surgery
- to replace lost fluid or blood volume
Read more
There are a variety of fluid choices doctors have to provide to patients, and it is still not definitively known whether some fluids are better than others in specific situations. This is a particularly interesting question in patients undergoing heart surgery because of the significant volume of fluids used over the entire course of hospitalization, including before the operation, during the operation, and after the operation.
There has been some scientific evidence that the use of starch-based fluids (synthetic colloids) leads to better oxygen delivery to the organs with a smaller volume of fluid given, providing for better recovery from surgery. However, there has also been some scientific evidence that the use of these fluids can harm kidney function. Importantly, none of these large-scale studies were carried out specifically in patients undergoing heart surgery.
The purpose of this study is to answer the question of whether the use of starch-based fluid in the heart surgery patient makes for a safer and faster recovery, causes kidney dysfunction, or makes no discernable difference.
- Conditions
- Coronary Artery Bypass Surgery
- Being tested
- 6% Hydroxyethyl Starch 130/0.4, 0.9% Normal Saline
- Keywords
- colloid fluid, crystalloid fluid, surgery, coronary artery bypass grafting, renal function, Patients undergoing coronary artery bypass surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6% Hydroxyethyl Starch 130/0.4Drug
0.9% Normal SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Starch group | Active comparator | Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements. Receives: Drug: 6% Hydroxyethyl Starch 130/0.4 |
| Saline group | Active comparator | Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements Receives: Drug: 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury as defined by RIFLE criteria
Measured: Short term (in hospital, up to 30 days) and mid-term (2 months)
Maximum postoperative weight gain
Measured: Short-term (in hospital, up to 7 days)
Secondary outcomes (10)
Operative mortality
Measured: In hospital (up to 30 days)
Duration of ventilation support requirements
Measured: In hospital (up to 30 days)
Total chest tube drainage (until removed)
Measured: In hospital (up to 30 days)
ICU length of stay
Measured: In hospital (up to 30 days)
Transfusion of blood products
Measured: In hospital (up to 30 days)
Incidence of atrial fibrillation (necessitating a change in medical management)
Measured: In hospital (up to 30 days)
Duration of oxygen supplementation
Measured: In hospital (up to 30 days)
Creatinine, Urea, Cr Clearance as estimated by the MDRD formula
Measured: In hospital at defined timepoints, and at 2 months post hospital discharge
Volume of fluid infused
Measured: In hospital (up to 7 days)
Total hospital length of stay (when ready to leave tertiary hospital setting)
Measured: In hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2010
- Study completionJun 2012
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dave Nagpal, London Health Sciences Centre
- Investigators
- Dave Nagpal, MD, Study director, LHSC / UWORay Guo, MD, Principal investigator, LHSC / UWOChris Harle, MD, Principal investigator, LHSC / UWO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964015
- Sponsor's protocol ID
- LHSC
- Acronym
- SSACS
- Status last verified
- Aug 2019
- First submitted
- 20 Aug 2009
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00964015
- Acronym / sponsor ID
- SSACS / LHSC
- Conditions
- Coronary Artery Bypass Surgery
- Keywords
- colloid fluid, crystalloid fluid, surgery, coronary artery bypass grafting, renal function, Patients undergoing coronary artery bypass surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Funding
- Enrolment
- 69 participants (actual)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Study start
- Aug 2009 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Aug 2009 (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.
When people undergo major surgery, they require intravenous supplementation of fluids for a number of reasons:
- to compensate for no oral intake
- to support blood pressure and organ function during and after surgery
- to replace lost fluid or blood volume
There are a variety of fluid choices doctors have to provide to patients, and it is still not definitively known whether some fluids are better than others in specific situations. This is a particularly interesting question in patients undergoing heart surgery because of the significant volume of fluids used over the entire course of hospitalization, including before the operation, during the operation, and after the operation.
There has been some scientific evidence that the use of starch-based fluids (synthetic colloids) leads to better oxygen delivery to the organs with a smaller volume of fluid given, providing for better recovery from surgery. However, there has also been some scientific evidence that the use of these fluids can harm kidney function. Importantly, none of these large-scale studies were carried out specifically in patients undergoing heart surgery.
The purpose of this study is to answer the question of whether the use of starch-based fluid in the heart surgery patient makes for a safer and faster recovery, causes kidney dysfunction, or makes no discernable difference.
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 |
|---|---|---|
| Starch group | Active comparator | Drug: 6% Hydroxyethyl Starch 130/0.4Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements. |
| Saline group | Active comparator | Drug: 0.9% Normal SalinePatients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective primary isolated on-pump coronary artery bypass grafting
Key exclusion criteria (5 listed)
- pregnant patients
- patients with an active intra-cranial bleed
- patients with a history of hypersensitivity to starch solutions
- patients with Stage 4 or 5 Kidney Disease (estimated glomerular filtration rate < 30 ml / min / 1.73 m2)
- patients with a significant preoperative metabolic acidosis, defined by a preoperative capillary blood pH less than or equal to 7.2 and a serum bicarbonate less than 15
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 | Drug | Starch group |
| 0.9% Normal Saline | Drug | Saline group |
Primary outcome
Incidence of acute kidney injury as defined by RIFLE criteria
Time frame: Short term (in hospital, up to 30 days) and mid-term (2 months)
Maximum postoperative weight gain
Time frame: Short-term (in hospital, up to 7 days)
10 secondary outcomes
Operative mortality
Time frame: In hospital (up to 30 days)
Duration of ventilation support requirements
Time frame: In hospital (up to 30 days)
Total chest tube drainage (until removed)
Time frame: In hospital (up to 30 days)
ICU length of stay
Time frame: In hospital (up to 30 days)
Transfusion of blood products
Time frame: In hospital (up to 30 days)
Incidence of atrial fibrillation (necessitating a change in medical management)
Time frame: In hospital (up to 30 days)
Duration of oxygen supplementation
Time frame: In hospital (up to 30 days)
Creatinine, Urea, Cr Clearance as estimated by the MDRD formula
Time frame: In hospital at defined timepoints, and at 2 months post hospital discharge
Volume of fluid infused
Time frame: In hospital (up to 7 days)
Total hospital length of stay (when ready to leave tertiary hospital setting)
Time frame: In hospital
Results and safety
The study was stopped early (reason given: Lack of Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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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.
Dave Nagpal, MD study director
LHSC / UWO
Ray Guo, MD principal investigator
LHSC / UWO
Chris Harle, MD principal investigator
LHSC / UWO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6% Hydroxyethyl Starch 130/0.4 and 0.9% Normal Saline in people with Coronary Artery Bypass Surgery, run by London Health Sciences 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 1 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: stopped early, as of the sponsor's last update on 15 Aug 2019. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of Funding). Results are not available in the source record.
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?
Incidence of acute kidney injury as defined by RIFLE criteria (time frame: Short term (in hospital, up to 30 days) and mid-term (2 months)). The study lists 2 primary outcomes in all. 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 15 Aug 2019.