Cardiac Surgical ProceduresPhase 4NCT00427388
Steroids In caRdiac Surgery Trial (SIRS Trial)
A Phase 4 study testing Methylprednisolone in people with Cardiac Surgical Procedures and Cardiopulmonary Bypass, run by Population Health Research Institute at 1 site in Canada.
Trial summary
SIRS trial is a large simple study in which high-risk patients undergoing cardiac surgery requiring the use of cardiopulmonary bypass (CPB) are randomly allocated to receive a pulse dose of Methylprednisolone or a matching placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Systemic Inflammatory Response Syndrome
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,507 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to Aug 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
- Age greater than 18 years
- Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures)
- Must have a EuroSCORE ≥ 6
- Provide written informed consent
- NOTE: For participating sites in India, China and Hong Kong, the following eligibility criteria will be applied:
- Age greater than 18 years
Show all 11Show fewer
- Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures)
- Must have at least one of the following:
- EuroSCORE greater than or equal to 4 and undergoing valvular surgery
- EuroSCORE greater than or equal to 6 and undergoing any other cardiac surgery procedure (i.e. CABG, Aorta)
- Provide written informed consent
Who cannot join
- Use of systemic corticosteroids
- History of bacterial or fungal infection in last 30 days
- Allergy/intolerance to corticosteroids
- Will receive Aprotinin
- Previous participation in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study of Perioperative Steroid's Effects on Death or MI in High-Risk Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass
SIRS trial is a large simple study in which high-risk patients undergoing cardiac surgery requiring the use of cardiopulmonary bypass (CPB) are randomly allocated to receive a pulse dose of Methylprednisolone or a matching placebo. Cardiopulmonary bypass initiates a systemic inflammatory response that facilitates development of post-operative complications. SIRS will confirm or deny the potential clinical benefits of suppressing this response through the use of systemic steroids. Specifically, does 250 mg of intravenous Methylprednisolone given twice, once on anesthetic induction and again on CPB initiation, result in improved early survival and less myocardial infarction in high-risk cardiac surgery patients requiring CPB?
Read the detailed description
Cardiopulmonary bypass (CPB) is a commonly performed surgical procedure with over 500,000 per year in North America. CPB initiates a systemic inflammatory response characterized by both cell and protein activation. Platelets, neutrophils, monocytes, macrophages, coagulation, fibrinolytic, and kallikrein cascades all take part in what results in increased endothelial permeability, vascular, and parenchymal damage. These inflammatory pathways facilitate development of post-operative complications including thrombosis, myocardial injury and infarction, respiratory failure, renal and neurological dysfunction, bleeding disorders, altered liver function and ultimately, multiple organ failure.
In an attempt to minimize the deleterious effects of CPB, investigators have tested a variety of strategies in cardiac surgery ranging from the complete avoidance of CPB, to the use of biocompatible circuits and pharmacologic agents to abrogate the systemic response. Investigators have consistently demonstrated the efficacy of steroids as the most potent anti-inflammatory agent for use during CPB. In fact, from the available evidence, the 2004 AHA guidelines for coronary artery bypass grafting (CABG) "support liberal prophylactic use in patients undergoing extracorporeal circulation". However, the trials that do exist within this literature are focused on biochemical endpoints and are insufficiently powered to make conclusions on hard clinical endpoints. Our pilot RCT, SIRS I, demonstrated the efficacy of a low dose steroid protocol in the suppression of this inflammatory cascade. We hypothesize that this low dose protocol will yield clinical benefit while avoiding the potential adverse effects of steroids which are known to be dose dependent.
The primary aim of the SIRS trial is to determine if perioperative pulse dose Methylprednisolone results in improved early survival and less myocardial infarction in cardiac surgery requiring CPB. Additional secondary aims of the SIRS trial are to determine the effect of steroids on other clinical outcomes including length of stay, new onset atrial fibrillation, transfusion requirements, infectious, wound, and gastrointestinal complications.
The design of the SIRS trial is a prospective multicentre international double-blind placebo controlled randomized clinical trial. The sample size of 7500 patients will have 80% to 90% power to detect a 20-30% RRR for the primary outcome with an α=0.05 (two-sided), anticipating a 6% rate of death in the control arm. Our aim is to have 85 international centers participate which, recruiting at 5 patients per month, would complete recruitment in 36 months. This will be a large trial with a simple design and objective outcomes.
A sub-group of patients will be enrolled in a renal sub-study. This sub-study will determine if the risk of acute kidney injury is lower in patients treated with intravenous steroid versus placebo, if steroids lead to better preservation of kidney function six months after cardiac surgery, and whether the impact of steroid exposure differs in patients with and without pre-operative chronic kidney disease.
- Conditions
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Systemic Inflammatory Response Syndrome
- Being tested
- Methylprednisolone, Placebo
- Keywords
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Systemic inflammatory Response Syndrome, Steroid, Myocardial Infarction, Randomized Clinical Trial
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Given by IV in 2 doses (250 mg each dose for a total of 500 mg)
PlaceboOther
Given in 2 IV doses (approximately 4 ml of 0.9% normal saline solution in each dose)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 500 mg of methylprednisolone divided into two intravenous doses of 250 mg each, one during anesthetic induction and the other on CPB initiation Receives: Drug: Methylprednisolone |
| Placebo | Placebo comparator | 500 mg of matching placebo (normal saline solution) divided into two intravenous doses of 250 mg each, one during anesthetic induction and the other on CPB initiation Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 30 days
Measured: 30 days post-randomization
Composite
Incidence of the composite outcome of death, myocardial infarction, stroke, renal failure (KDIGO Stage III acute kidney injury, 2012 Kidney Disease Improving Global Outcomes (KDIGO) guidelines), or respiratory failure within 30 days
Measured: 30 days post-randomization
Secondary outcomes (12)
MI or Mortality at 30 days
Composite of death or significant myocardial infarction within 30 days post-randomization
Measured: 30 days post-randomization
Mortality at 6 months
All-cause mortality at 6 months post-randomization
Measured: 6 months post-randomization
Atrial Fibrillation
New onset atrial fibrillation within 30 days post-randomization
Measured: 30 days post-randomization
Transfusion Requirements
Transfusion requirements within first 24 hours post-operative
Measured: 24 hours post-surgery
Chest Tube Output
Chest tube output within first 24 hours post-operative
Measured: 24 hours post-surgery
ICU and Hospital Length of Stay
Length of ICU stay and hospital stay
Measured: Hospital Discharge
Infection
Infection within 30 days post-randomization
Measured: 30 days post-randomization
Delirium
Delirium at day 3 post-operative
Measured: 3 days post-surgery
Wound Complication
Wound complication within 30 days post-randomization
Measured: 30 days post-randomization
GI Hemorrhage
GI hemorrhage or GI perforation within 30 days post-randomization
Measured: 30 days post-randomization
Insulin Use
Post-operative insulin use within the first 24 hours after surgery
Measured: 24 hours post-surgery
Peak Blood Glucose
Peak blood glucose within the first 24 hours after surgery
Measured: 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2014
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgical ProceduresStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7,507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Richard Whitlock, McMaster University
- Investigators
- Salim Yusuf, MD, DPhil, Principal investigator, Pranic Healing Research InstituteKevin Teoh, MD, MSc, Principal investigator, McMaster UniversityRichard P Whitlock, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427388
- Sponsor's protocol ID
- SIRS 2007
- Status last verified
- Jul 2014
- First submitted
- 26 Jan 2007
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Whitlock RP, Young E, Noora J, Farrokhyar F, Blackall M, Teoh KH. Pulse low dose steroids attenuate post-cardiopulmonary bypass SIRS; SIRS I. J Surg Res. 2006 May 15;132(2):188-94. doi: 10.1016/j.jss.2006.02.013. Epub 2006 Mar 29.
PubMed 16566943Whitlock RP, Rubens FD, Young E, Teoh KH. Pro: Steroids should be used for cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2005 Apr;19(2):250-4. doi: 10.1053/j.jvca.2005.02.010. No abstract available.
PubMed 15868539Whitlock R, Teoh K, Vincent J, Devereaux PJ, Lamy A, Paparella D, Zuo Y, Sessler DI, Shah P, Villar JC, Karthikeyan G, Urrutia G, Alvezum A, Zhang X, Abbasi SH, Zheng H, Quantz M, Yared JP, Yu H, Noiseux N, Yusuf S. Rationale and design of the steroids in cardiac surgery trial. Am Heart J. 2014 May;167(5):660-5. doi: 10.1016/j.ahj.2014.01.018. Epub 2014 Mar 1.
PubMed 24766975Garg AX, Vincent J, Cuerden M, Parikh C, Devereaux PJ, Teoh K, Yusuf S, Hildebrand A, Lamy A, Zuo Y, Sessler DI, Shah P, Abbasi SH, Quantz M, Yared JP, Noiseux N, Tagarakis G, Rochon A, Pogue J, Walsh M, Chan MT, Lamontagne F, Salehiomran A, Whitlock R; SIRS Investigators. Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial. BMJ Open. 2014 Mar 5;4(3):e004842. doi: 10.1136/bmjopen-2014-004842.
PubMed 24598306Garg AX, Chan MTV, Cuerden MS, Devereaux PJ, Abbasi SH, Hildebrand A, Lamontagne F, Lamy A, Noiseux N, Parikh CR, Perkovic V, Quantz M, Rochon A, Royse A, Sessler DI, Shah PJ, Sontrop JM, Tagarakis GI, Teoh KH, Vincent J, Walsh M, Yared JP, Yusuf S, Whitlock RP; SIRS Investigators. Effect of methylprednisolone on acute kidney injury in patients undergoing cardiac surgery with a cardiopulmonary bypass pump: a randomized controlled trial. CMAJ. 2019 Mar 4;191(9):E247-E256. doi: 10.1503/cmaj.181644.
PubMed 30833491Theriault S, Whitlock R, Raman K, Vincent J, Yusuf S, Pare G. Gene Expression Profiles for the Identification of Prevalent Atrial Fibrillation. J Am Heart Assoc. 2017 Jun 30;6(7):e006057. doi: 10.1161/JAHA.117.006057.
PubMed 28666990Whitlock RP, Devereaux PJ, Teoh KH, Lamy A, Vincent J, Pogue J, Paparella D, Sessler DI, Karthikeyan G, Villar JC, Zuo Y, Avezum A, Quantz M, Tagarakis GI, Shah PJ, Abbasi SH, Zheng H, Pettit S, Chrolavicius S, Yusuf S; SIRS Investigators. Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Sep 26;386(10000):1243-1253. doi: 10.1016/S0140-6736(15)00273-1.
PubMed 26460660
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Perioperative Steroid's Effects on Death or MI in High-Risk Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00427388
- Acronym / sponsor ID
- SIRS 2007
- Conditions
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Systemic Inflammatory Response Syndrome
- Keywords
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Systemic inflammatory Response Syndrome, Steroid, Myocardial Infarction, Randomized Clinical Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,507 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2007
- Primary completion
- Feb 2014 (actual)
- Study completion
- Aug 2014 (estimated)
- First posted
- 29 Jan 2007 (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.
SIRS trial is a large simple study in which high-risk patients undergoing cardiac surgery requiring the use of cardiopulmonary bypass (CPB) are randomly allocated to receive a pulse dose of Methylprednisolone or a matching placebo. Cardiopulmonary bypass initiates a systemic inflammatory response that facilitates development of post-operative complications. SIRS will confirm or deny the potential clinical benefits of suppressing this response through the use of systemic steroids. Specifically, does 250 mg of intravenous Methylprednisolone given twice, once on anesthetic induction and again on CPB initiation, result in improved early survival and less myocardial infarction in high-risk cardiac surgery patients requiring CPB?
Detailed description
Cardiopulmonary bypass (CPB) is a commonly performed surgical procedure with over 500,000 per year in North America. CPB initiates a systemic inflammatory response characterized by both cell and protein activation. Platelets, neutrophils, monocytes, macrophages, coagulation, fibrinolytic, and kallikrein cascades all take part in what results in increased endothelial permeability, vascular, and parenchymal damage. These inflammatory pathways facilitate development of post-operative complications including thrombosis, myocardial injury and infarction, respiratory failure, renal and neurological dysfunction, bleeding disorders, altered liver function and ultimately, multiple organ failure.
In an attempt to minimize the deleterious effects of CPB, investigators have tested a variety of strategies in cardiac surgery ranging from the complete avoidance of CPB, to the use of biocompatible circuits and pharmacologic agents to abrogate the systemic response. Investigators have consistently demonstrated the efficacy of steroids as the most potent anti-inflammatory agent for use during CPB. In fact, from the available evidence, the 2004 AHA guidelines for coronary artery bypass grafting (CABG) "support liberal prophylactic use in patients undergoing extracorporeal circulation". However, the trials that do exist within this literature are focused on biochemical endpoints and are insufficiently powered to make conclusions on hard clinical endpoints. Our pilot RCT, SIRS I, demonstrated the efficacy of a low dose steroid protocol in the suppression of this inflammatory cascade. We hypothesize that this low dose protocol will yield clinical benefit while avoiding the potential adverse effects of steroids which are known to be dose dependent.
The primary aim of the SIRS trial is to determine if perioperative pulse dose Methylprednisolone results in improved early survival and less myocardial infarction in cardiac surgery requiring CPB. Additional secondary aims of the SIRS trial are to determine the effect of steroids on other clinical outcomes including length of stay, new onset atrial fibrillation, transfusion requirements, infectious, wound, and gastrointestinal complications.
The design of the SIRS trial is a prospective multicentre international double-blind placebo controlled randomized clinical trial. The sample size of 7500 patients will have 80% to 90% power to detect a 20-30% RRR for the primary outcome with an α=0.05 (two-sided), anticipating a 6% rate of death in the control arm. Our aim is to have 85 international centers participate which, recruiting at 5 patients per month, would complete recruitment in 36 months. This will be a large trial with a simple design and objective outcomes.
A sub-group of patients will be enrolled in a renal sub-study. This sub-study will determine if the risk of acute kidney injury is lower in patients treated with intravenous steroid versus placebo, if steroids lead to better preservation of kidney function six months after cardiac surgery, and whether the impact of steroid exposure differs in patients with and without pre-operative chronic kidney disease.
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 |
|---|---|---|
| Treatment | Experimental | Drug: Methylprednisolone500 mg of methylprednisolone divided into two intravenous doses of 250 mg each, one during anesthetic induction and the other on CPB initiation |
| Placebo | Placebo comparator | Other: Placebo500 mg of matching placebo (normal saline solution) divided into two intravenous doses of 250 mg each, one during anesthetic induction and the other on CPB initiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age greater than 18 years
- Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures)
- Must have a EuroSCORE ≥ 6
- Provide written informed consent
- NOTE: For participating sites in India, China and Hong Kong, the following eligibility criteria will be applied:
Key exclusion criteria (5 listed)
- Use of systemic corticosteroids
- History of bacterial or fungal infection in last 30 days
- Allergy/intolerance to corticosteroids
- Will receive Aprotinin
- Previous participation in study
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 |
|---|---|---|
| MethylprednisoloneGiven by IV in 2 doses (250 mg each dose for a total of 500 mg) | Drug | Treatment |
| PlaceboGiven in 2 IV doses (approximately 4 ml of 0.9% normal saline solution in each dose) | Other | Placebo |
Primary outcome
Mortality at 30 days
Time frame: 30 days post-randomization
Composite
Time frame: 30 days post-randomization
Incidence of the composite outcome of death, myocardial infarction, stroke, renal failure (KDIGO Stage III acute kidney injury, 2012 Kidney Disease Improving Global Outcomes (KDIGO) guidelines), or respiratory failure within 30 days
12 secondary outcomes
MI or Mortality at 30 days
Time frame: 30 days post-randomization
Mortality at 6 months
Time frame: 6 months post-randomization
Atrial Fibrillation
Time frame: 30 days post-randomization
Transfusion Requirements
Time frame: 24 hours post-surgery
Chest Tube Output
Time frame: 24 hours post-surgery
ICU and Hospital Length of Stay
Time frame: Hospital Discharge
Infection
Time frame: 30 days post-randomization
Delirium
Time frame: 3 days post-surgery
Wound Complication
Time frame: 30 days post-randomization
GI Hemorrhage
Time frame: 30 days post-randomization
Insulin Use
Time frame: 24 hours post-surgery
Peak Blood Glucose
Time frame: 24 hours post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
- Background: PubMed 16566943Whitlock RP, Young E, Noora J, Farrokhyar F, Blackall M, Teoh KH. Pulse low dose steroids attenuate post-cardiopulmonary bypass SIRS; SIRS I. J Surg Res. 2006 May 15;132(2):188-94. doi: 10.1016/j.jss.2006.02.013. Epub 2006 Mar 29.
- Background: PubMed 15868539Whitlock RP, Rubens FD, Young E, Teoh KH. Pro: Steroids should be used for cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2005 Apr;19(2):250-4. doi: 10.1053/j.jvca.2005.02.010. No abstract available.
- Background: PubMed 24766975Whitlock R, Teoh K, Vincent J, Devereaux PJ, Lamy A, Paparella D, Zuo Y, Sessler DI, Shah P, Villar JC, Karthikeyan G, Urrutia G, Alvezum A, Zhang X, Abbasi SH, Zheng H, Quantz M, Yared JP, Yu H, Noiseux N, Yusuf S. Rationale and design of the steroids in cardiac surgery trial. Am Heart J. 2014 May;167(5):660-5. doi: 10.1016/j.ahj.2014.01.018. Epub 2014 Mar 1.
- Background: PubMed 24598306Garg AX, Vincent J, Cuerden M, Parikh C, Devereaux PJ, Teoh K, Yusuf S, Hildebrand A, Lamy A, Zuo Y, Sessler DI, Shah P, Abbasi SH, Quantz M, Yared JP, Noiseux N, Tagarakis G, Rochon A, Pogue J, Walsh M, Chan MT, Lamontagne F, Salehiomran A, Whitlock R; SIRS Investigators. Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial. BMJ Open. 2014 Mar 5;4(3):e004842. doi: 10.1136/bmjopen-2014-004842.
- Derived from this study: PubMed 30833491Garg AX, Chan MTV, Cuerden MS, Devereaux PJ, Abbasi SH, Hildebrand A, Lamontagne F, Lamy A, Noiseux N, Parikh CR, Perkovic V, Quantz M, Rochon A, Royse A, Sessler DI, Shah PJ, Sontrop JM, Tagarakis GI, Teoh KH, Vincent J, Walsh M, Yared JP, Yusuf S, Whitlock RP; SIRS Investigators. Effect of methylprednisolone on acute kidney injury in patients undergoing cardiac surgery with a cardiopulmonary bypass pump: a randomized controlled trial. CMAJ. 2019 Mar 4;191(9):E247-E256. doi: 10.1503/cmaj.181644.
- Derived from this study: PubMed 28666990Theriault S, Whitlock R, Raman K, Vincent J, Yusuf S, Pare G. Gene Expression Profiles for the Identification of Prevalent Atrial Fibrillation. J Am Heart Assoc. 2017 Jun 30;6(7):e006057. doi: 10.1161/JAHA.117.006057.
- Derived from this study: PubMed 26460660Whitlock RP, Devereaux PJ, Teoh KH, Lamy A, Vincent J, Pogue J, Paparella D, Sessler DI, Karthikeyan G, Villar JC, Zuo Y, Avezum A, Quantz M, Tagarakis GI, Shah PJ, Abbasi SH, Zheng H, Pettit S, Chrolavicius S, Yusuf S; SIRS Investigators. Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Sep 26;386(10000):1243-1253. doi: 10.1016/S0140-6736(15)00273-1.
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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.
Salim Yusuf, MD, DPhil principal investigator
Pranic Healing Research Institute
Kevin Teoh, MD, MSc principal investigator
McMaster University
Richard P Whitlock, MD, MSc principal investigator
McMaster University
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 Methylprednisolone in people with Cardiac Surgical Procedures and Cardiopulmonary Bypass, run by Population Health Research Institute 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 11 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: status not confirmed, as of the sponsor's last update on 4 Aug 2014. 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. Some participants in this study may receive a placebo. 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?
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?
Mortality at 30 days (time frame: 30 days post-randomization). 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?
On the ClinicalTrials.gov record for NCT00427388, which also lists 7 linked publications.
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 4 Aug 2014.