Cardiac Surgical ProceduresNCT02329158
Disinvestment in Hydroxyl-ethyl Starches (HES) for Cardiac Surgery
An observational study of Cardiac Surgical Procedures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
The purpose of this study is to determine whether disinvestment in hydroxyl-ethyl starches (HES) for patients undergoing cardiac surgery was safe and effective. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgical Procedures
- What is being tested?
- 6% hydroxyethyl starch
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Apr 2018
- Phase
- Observational
- 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
Study population: The proposed study population includes adult patients (age >/= 18) who underwent coronary artery bypass surgery (CABG) with or without valve surgery at the London Health Sciences Centre.
Who may be able to join
- The London Health Sciences Centre disinvested in hydroxyethyl starches on April 2, 2013. The study population will include individuals undergoing cardiac surgery and discharged from hospital in one of two eras:
- Era 1 (365 days prior to disinvestment in HES): the time period between April 1, 2012 and March 31, 2013, or
- Era 2 (365 days following disinvestment in HES): the time period between June 1, 2013 and May 31, 2014 (NB: after a 2-month washout period to ensure all HES supplies had been exhausted).
- Specifically, the study population will be comprised of patients who underwent the following cardiac surgical procedures:
- Coronary artery bypass graft only
- Coronary artery bypass graft with aortic valve replacement
Show all 10Show fewer
- Coronary artery bypass graft with aortic valve repair
- Coronary artery bypass graft with mitral valve replacement
- Coronary artery bypass graft with mitral valve repair
- Coronary artery bypass graft with a valve surgical procedure (replacement and/or repair) involving up two valves
Who cannot join
- Individuals undergoing heart transplants, aortic dissections, and other cardiac procedures not listed in the inclusion criteria above will be excluded.
- Individuals with any portion of the acute length of stay spanning the washout period (April 1, 2013 to May 31, 2013) will be excluded. Specifically, the following patients will be excluded:
- Patients admitted prior to April 1, 2013 that remained in hospital on April 1, 2013.
- Patients admitted during the washout period (April 1, 2013 to May 31, 2013) that remained in hospital on May 31, 2013.
- Patients admitted and discharged during the washout period.
- We will exclude subsequent cardiac surgical procedures for individuals meeting the inclusion criteria more than once during the study timeframe (i.e. each patient's data will only be used once).
- Individuals enrolled in the randomized controlled clinical trial entitled, "VolulyteTM in Cardiac Surgery" (ClinicalTrials.gov Identifier: NCT01553617) will be excluded from the cohort. The purpose of this study was to assess the efficacy and safety of 6 % Hydroxyethyl Starch 130/0.4 in an Isotonic Electrolyte Solution (VolulyteTM) compared to 5% Human Serum Albumin as volume replacement therapy in elective open-heart surgery in adult patients on cardiopulmonary bypass. Individuals enrolled in the trial were randomized to priming of the cardiopulmonary bypass machine and volume therapy as necessary with either Volulyte or Human Serum Albumin. The study began in October 2012 and was completed in January 2014, with a total enrolment of 133 patients. The approximate number enrolled at LHSC was 30. Because the study period overlaps with that of the pre- and post- disinvestment eras, individuals enrolled in this study will be excluded from the retrospective cohort.
About this study
Official title: Clinical Impact of Disinvestment in Hydroxyl-ethyl Starches (HES) for Patients Undergoing Cardiac Surgery
The purpose of this study is to determine whether disinvestment in hydroxyl-ethyl starches (HES) for patients undergoing cardiac surgery was safe and effective.
Read the detailed description
Fluid replacement therapy is administered to patients requiring volume resuscitation following significant blood loss, or for maintenance fluid requirements. Severe blood loss can lead to anemia, reduced oxygen carrying capacity, and organ failure. Options for fluid replacement include red blood cell transfusion, colloids such as hydroxyethyl starches (HES), albumin, and gelatin as well as crystalloids such as normal saline and Ringer's lactate. Until recently, use of HES at the London hospitals and other major health sciences centers was concentrated in cardiac surgery patients and non-critically ill perioperative patients. In April 2013, the London Health Sciences Centre (LHSC) opted to discontinue the use of HES altogether, based on evidence suggesting that HES may be harmful compared to alternative fluid therapies.
The decision to disinvest in HES became effective on April 2, 2013. The hospitals no longer purchased HES, and clinicians used alternative fluids for volume resuscitation. Alternatives available at the hospitals included Ringer's lactate, normal saline, and albumin. All HES product was removed from patient care areas.
The investigators will perform a before/after analysis of the impact of HES disinvestment using a retrospective observational cohort study design, employing data obtained from administrative and clinical databases. Exposure to HES before disinvestment will be assumed to be 100% of cardiac surgical patients, and, after a washout period surrounding the time of disinvestment, exposure to HES will be assumed to be 0% after disinvestment.
The study population will be defined retrospectively in terms of the intervention received and the time period of the intervention.
- Conditions
- Cardiac Surgical Procedures
- Being tested
- 6% hydroxyethyl starch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6% hydroxyethyl starchDrug
Also called Voluven (Fresenius Kabi)
| Study group | Role | What they receive |
|---|---|---|
| Arm: Exposed: Hydroxyethyl starch | Cardiac surgical patients exposed to 6% hydroxyethyl starch (130/0.4). Receives: Drug: 6% hydroxyethyl starch | |
| Arm: Unexposed: Hydroxyethyl starch | Cardiac surgical patients not exposed to 6% hydroxyethyl starch (130/0.4). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Acute hospital length of stay (in days) following cardiac surgery
Measured: Following cardiac surgery (on average approximately 10 days)
Secondary outcomes (6)
Rates of transfusion
The proportion receiving a transfusion of red blood cells or other products.
Measured: During or after cardiac surgery, prior to hospital discharge (on average approximately 10 days)
Rates of transfusion
The number of units of red blood cells or other products transfused.
Measured: During or after cardiac surgery, prior to hospital discharge (on average approximately 10 days)
Kidney Injury
The proportion experiencing kidney injury as measured by serum creatinine levels.
Measured: During or after cardiac surgery, prior to hospital discharge (on average approximately 10 days)
Renal Replacement Therapy
The proportion receiving renal replacement therapy.
Measured: During or after cardiac surgery, prior to hospital discharge (on average approximately 10 days)
Cost of care
The total cost of the acute phase of hospitalization based on hospital case cost data.
Measured: During the acute phase of the hospital stay (on average approximately 10 days)
In-hospital mortality
The proportion dying during the hospital stay.
Measured: Death during the hospital stay (on average approximately 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionApr 2018
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 Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329158
- Sponsor's protocol ID
- 105755
- Status last verified
- Nov 2018
- First submitted
- 22 Dec 2014
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hong M, Jones PM, Martin J, Kiaii B, Arellano R, Cheng D, John-Baptiste AA. Clinical impact of disinvestment in hydroxyethyl starch for patients undergoing coronary artery bypass surgery: a retrospective observational study. Can J Anaesth. 2019 Jan;66(1):25-35. doi: 10.1007/s12630-018-1245-5. Epub 2018 Nov 8.
PubMed 30411246
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Disinvestment in Hydroxyl-ethyl Starches (HES) for Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02329158
- Acronym / sponsor ID
- 105755
- Conditions
- Cardiac Surgical Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Western University, Canada
- Study start
- May 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 31 Dec 2014 (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 purpose of this study is to determine whether disinvestment in hydroxyl-ethyl starches (HES) for patients undergoing cardiac surgery was safe and effective.
Detailed description
Fluid replacement therapy is administered to patients requiring volume resuscitation following significant blood loss, or for maintenance fluid requirements. Severe blood loss can lead to anemia, reduced oxygen carrying capacity, and organ failure. Options for fluid replacement include red blood cell transfusion, colloids such as hydroxyethyl starches (HES), albumin, and gelatin as well as crystalloids such as normal saline and Ringer's lactate. Until recently, use of HES at the London hospitals and other major health sciences centers was concentrated in cardiac surgery patients and non-critically ill perioperative patients. In April 2013, the London Health Sciences Centre (LHSC) opted to discontinue the use of HES altogether, based on evidence suggesting that HES may be harmful compared to alternative fluid therapies.
The decision to disinvest in HES became effective on April 2, 2013. The hospitals no longer purchased HES, and clinicians used alternative fluids for volume resuscitation. Alternatives available at the hospitals included Ringer's lactate, normal saline, and albumin. All HES product was removed from patient care areas.
The investigators will perform a before/after analysis of the impact of HES disinvestment using a retrospective observational cohort study design, employing data obtained from administrative and clinical databases. Exposure to HES before disinvestment will be assumed to be 100% of cardiac surgical patients, and, after a washout period surrounding the time of disinvestment, exposure to HES will be assumed to be 0% after disinvestment.
The study population will be defined retrospectively in terms of the intervention received and the time period of the intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm: Exposed: Hydroxyethyl starch | – | Drug: 6% hydroxyethyl starchCardiac surgical patients exposed to 6% hydroxyethyl starch (130/0.4). |
| Arm: Unexposed: Hydroxyethyl starch | – | –Cardiac surgical patients not exposed to 6% hydroxyethyl starch (130/0.4). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The proposed study population includes adult patients (age >/= 18) who underwent coronary artery bypass surgery (CABG) with or without valve surgery at the London Health Sciences Centre.
Key inclusion criteria (10 listed)
- The London Health Sciences Centre disinvested in hydroxyethyl starches on April 2, 2013. The study population will include individuals undergoing cardiac surgery and discharged from hospital in one of two eras:
- Specifically, the study population will be comprised of patients who underwent the following cardiac surgical procedures:
Key exclusion criteria (7 listed)
- Individuals undergoing heart transplants, aortic dissections, and other cardiac procedures not listed in the inclusion criteria above will be excluded.
- Individuals with any portion of the acute length of stay spanning the washout period (April 1, 2013 to May 31, 2013) will be excluded. Specifically, the following patients will be excluded:
- We will exclude subsequent cardiac surgical procedures for individuals meeting the inclusion criteria more than once during the study timeframe (i.e. each patient's data will only be used once).
- Individuals enrolled in the randomized controlled clinical trial entitled, "VolulyteTM in Cardiac Surgery" (ClinicalTrials.gov Identifier: NCT01553617) will be excluded from the cohort. The purpose of this study was to assess the efficacy and safety of 6 % Hydroxyethyl Starch 130/0.4 in an Isotonic Electrolyte Solution (VolulyteTM) compared to 5% Human Serum Albumin as volume replacement therapy in elective open-heart surgery in adult patients on cardiopulmonary bypass. Individuals enrolled in the trial were randomized to priming of the cardiopulmonary bypass machine and volume therapy as necessary with either Volulyte or Human Serum Albumin. The study began in October 2012 and was completed in January 2014, with a total enrolment of 133 patients. The approximate number enrolled at LHSC was 30. Because the study period overlaps with that of the pre- and post- disinvestment eras, individuals enrolled in this study will be excluded from the retrospective cohort.
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 starchAlso: Voluven (Fresenius Kabi) | Drug | Arm: Exposed: Hydroxyethyl starch |
Primary outcome
Length of Stay
Time frame: Following cardiac surgery (on average approximately 10 days)
Acute hospital length of stay (in days) following cardiac surgery
6 secondary outcomes
Rates of transfusion
Time frame: During or after cardiac surgery, prior to hospital discharge (on average approximately 10 days)
Rates of transfusion
Time frame: During or after cardiac surgery, prior to hospital discharge (on average approximately 10 days)
Kidney Injury
Time frame: During or after cardiac surgery, prior to hospital discharge (on average approximately 10 days)
Renal Replacement Therapy
Time frame: During or after cardiac surgery, prior to hospital discharge (on average approximately 10 days)
Cost of care
Time frame: During the acute phase of the hospital stay (on average approximately 10 days)
In-hospital mortality
Time frame: Death during the hospital stay (on average approximately 10 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 6 Nov 2018.
- Derived from this study: PubMed 30411246Hong M, Jones PM, Martin J, Kiaii B, Arellano R, Cheng D, John-Baptiste AA. Clinical impact of disinvestment in hydroxyethyl starch for patients undergoing coronary artery bypass surgery: a retrospective observational study. Can J Anaesth. 2019 Jan;66(1):25-35. doi: 10.1007/s12630-018-1245-5. Epub 2018 Nov 8.
Related trials for Cardiac Surgical Procedures
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgical Procedures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 10 inclusion and 7 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Length of Stay (time frame: Following cardiac surgery (on average approximately 10 days)). 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 NCT02329158, 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 6 Nov 2018.