Nosocomial InfectionGLADIATORNCT01704430
Glutamine to Improve Outcomes in Cardiac Surgery
A study testing Glutamine and Maltodextrin in people with Nosocomial Infection, run by University of Alberta at 2 sites in Canada.
Trial summary
Patients undergoing heart surgery with a heart-lung machine (termed cardiopulmonary bypass) are at an increased risk of having abnormal "inflammation" in their body after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nosocomial Infection
- What is being tested?
- Glutamine and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2012to 21 Jun 2016
- 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
- Consent (obtained pre-operatively)
- Adult - aged 18 years or older;
- Planned cardiovascular surgery with cardiopulmonary bypass;
- Increased risk for post-operative morbidity, defined by a pre-operative European System for Operative Cardiac Risk Evaluation (EuroSCORE) > 6;
- Able to receive enteral nutrition through nasal/oral gastric or post-pyloric feeding tube.
Who cannot join
- Planned heart or lung transplantation
- Planned cardiovascular surgery without cardiopulmonary bypass;
- Peri-operative support with extracorporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta
Edmonton, Alberta, T6G 2B7
Mazankowski Alberta Heart Institute, University of Alberta
Edmonton, Alberta, T6G2B7
About this study
Official title: GLutamine Enterally After carDiac Surgery for Inflammation Attenuation and ouTcOme impRovement (GLADIATOR): A Phase II Randomized, Blinded, Placebo-Controlled Trial
Patients undergoing heart surgery with a heart-lung machine (termed cardiopulmonary bypass) are at an increased risk of having abnormal "inflammation" in their body after surgery. Such inflammation can contribute to slower recovery from surgery, an increased risk of infection, an increased risk of damage to organs other than the heart, and a more complicated course.
Prior research has suggested that using an oral protein supplement made of glutamine (an essential amino acid normally found in your body) can reduce the risk of inflammation, infection and the length of stay in hospital in patients who have suffered major trauma or a burn injury. The investigators believe reducing such inflammation after heart surgery may help promote recovery and reduce the risk of adverse events and complications.
The purpose of this preliminary study is to see if oral glutamine supplementation after heart surgery is practical, and contributes to a reduction in inflammation. The oral glutamine proposed in this study is based on what has been previously studied and what is considered safe.
Read the detailed description
Hypothesis: We believe that early post-operative administration of enteral glutamine following cardiac surgery with cardiopulmonary bypass (CPB) in high risk patients will reduce inflammation and nonscomial infections, reduce length of ventilator support, reduce need for vasoactive support, reduce secondary organ dysfunction, reduce length of hospital stay in the CVICU, and reduce mortality.
Objectives:
- To assess the feasibility of early glutamine supplementation
- To evaluate the safety profile of early glutamine supplementation
- To evaluate efficacy the impact of early glutamine on clinically important post-operative complications and outcomes, including: systemic inflammation, nosocomial infections, mortality, and health resource utilization
Methods: Study Design, Setting, and Patient Population: The proposed study is a Phase II, randomized, blinded, placebo-controlled trial. This trial will be performed in the Cardiovascular Surgical Intensive Care Unit (CVICU) of the Mazankowski Alberta Heart Institute (MAHI), Alberta Health Services. The proposed trial plans to enroll 100 consecutive eligible patients.
Inclusion:
- Consent (obtained pre-operatively)
- Adult - aged 18 years or older;
- Planned cardiac surgery with CPB;
- Elevated risk for post-operative morbidity, defined by a pre-operative European System for Operative Cardiac Risk Evaluation (EuroSCORE) > 6.
- Able to receive enteral nutrition through nasal/oral gastric or post-pyloric feeding tube.
Exclusion:
- Planned heart or lung transplantation
- Planned cardiac surgery without cardiopulmonary bypass;
- Peri-operative support with extracorporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD).
Study Protocol: Eligible patients will be identified during pre-operative assessment in the pre-operative clinic (PAC). All eligible patients or their surrogate decision-making/legal guardian will then be approached to obtain informed written consent.
Each consenting participant will be randomly allocated (1:1) to receive post-operative enteral glutamine or identical placebo. Investigators, surgeons, intensivists, bedside nurses and participants will remain blinded to study allocation.
Glutamine supplementation will be dosed at 0.5 g/kg satisfactory body weight (SBW)/day divided every 8 hours, starting 6 hours post-operatively and continued for 5 days. The dose of 0.5 g/kg SBW/day was effective in clinical studies using enteral glutamine in critically ill and/or burn injured and major trauma patients. The glutamine supplementation or placebo will be delivered via naso- or oro-gastric feeding tube after confirmation of placement by chest X-ray. For participants who are extubated prior to 5 days, enteral glutamine will be given by mouth for the duration of the 5 day period. Glutamine and placebo will be mixed in orange juice to maintain blinding.
- Conditions
- Nosocomial Infection
- Being tested
- Glutamine, Maltodextrin
- Keywords
- Cardiac surgery, Cardiac bypass, Intensive Care, Nosocomial infection, Glutamine, Randomized trial
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDietary supplement
Also called L-Glutamine
Enteric L-Glutamine
MaltodextrinDietary supplement
Enteric Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Experimental | Oral/enteral glutamine 0.5 g/kg satisfactory body weight per day (divided doses every 8 hours) starting 6 hours post-operatively Receives: Dietary Supplement: Glutamine |
| Maltodextrin | Placebo comparator | Oral/enteral maltodextrin 0.5 g/kg satisfactory body weight per day (divided doses every 8 hours) starting 6 hours post-operatively Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Eligible Patients Providing Consent to Participate
Assess the FEASIBILITY of the protocol to (i) achieve >75% consent rate in eligible patients
Measured: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Secondary outcomes (9)
Acute Kidney Injury
Measured: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Duration of mechanical ventilation
Measured: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Duration of vasoactive support
Measured: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Blood transfusion
Measured: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Organ Dysfunction Score
Post-operative changes to the Sequential Organ Failure Assessment score
Measured: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Adverse events
Evaluate the SAFETY and ADVERSE EFFECTS of (i) enteral glutamine; and (ii) COMPLICATIONS from feeding tube placement, including: epistaxis, feeding tube malposition, pneumothorax, esophageal injury, gastric mucosal irritation, gastrointestinal bleeding, unplanned feeding tube removal, and need for feeding tube reinsertion
Measured: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Systemic inflammation
Systemic Inflammation/immunomodulation: We will evaluate for increases and changes in systemic inflammation stratified by study intervention. This will aid in providing proof-of-concept of the biologic plausibility of the study intervention. The investigators propose to evaluate serial measures of C-reactive protein (CRP), chemiluminescent endotoxin activity assay (EAA), and interleukin-6 (IL-6).
Measured: Date of surgery until the end of planned study intervention, expected 5-days
Nosocomial infection
Nosocomial infections: The investigators will specifically examine for the following infections during the period of hospitalization after surgery: superficial and deep sternal wound infections; mediastinitis; saphenous vein graft harvest site wound infections; ventilator associated and hospital acquired pneumonia; urinary tract infections; bloodstream infections; catheter-related blood stream infections; and decubitus ulcers.
Measured: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Proportion of Randomized Patients Achieving Protocol Adherence
Obtain > 90% protocol adherence
Measured: 5-days (date of surgery until the end of planned study intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startSep 2012
- Primary completion21 Jun 2016
- Study completion21 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial InfectionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Glutamine
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Bagshaw, Principal investigator, University of AlbertaGurmeet Singh, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704430
- Sponsor's protocol ID
- MAZ_CVICU_001
- Acronym
- GLADIATOR
- Status last verified
- Feb 2017
- First submitted
- 22 Aug 2012
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLutamine Enterally After carDiac Surgery for Inflammation Attenuation and ouTcOme impRovement (GLADIATOR): A Phase II Randomized, Blinded, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01704430
- Acronym / sponsor ID
- GLADIATOR / MAZ_CVICU_001
- Conditions
- Nosocomial Infection
- Keywords
- Cardiac surgery, Cardiac bypass, Intensive Care, Nosocomial infection, Glutamine, Randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 21 Jun 2016 (actual)
- Study completion
- 21 Jun 2016 (actual)
- First posted
- 11 Oct 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.
Patients undergoing heart surgery with a heart-lung machine (termed cardiopulmonary bypass) are at an increased risk of having abnormal "inflammation" in their body after surgery. Such inflammation can contribute to slower recovery from surgery, an increased risk of infection, an increased risk of damage to organs other than the heart, and a more complicated course.
Prior research has suggested that using an oral protein supplement made of glutamine (an essential amino acid normally found in your body) can reduce the risk of inflammation, infection and the length of stay in hospital in patients who have suffered major trauma or a burn injury. The investigators believe reducing such inflammation after heart surgery may help promote recovery and reduce the risk of adverse events and complications.
The purpose of this preliminary study is to see if oral glutamine supplementation after heart surgery is practical, and contributes to a reduction in inflammation. The oral glutamine proposed in this study is based on what has been previously studied and what is considered safe.
Detailed description
Hypothesis: We believe that early post-operative administration of enteral glutamine following cardiac surgery with cardiopulmonary bypass (CPB) in high risk patients will reduce inflammation and nonscomial infections, reduce length of ventilator support, reduce need for vasoactive support, reduce secondary organ dysfunction, reduce length of hospital stay in the CVICU, and reduce mortality.
Objectives:
- To assess the feasibility of early glutamine supplementation
- To evaluate the safety profile of early glutamine supplementation
- To evaluate efficacy the impact of early glutamine on clinically important post-operative complications and outcomes, including: systemic inflammation, nosocomial infections, mortality, and health resource utilization
Methods: Study Design, Setting, and Patient Population: The proposed study is a Phase II, randomized, blinded, placebo-controlled trial. This trial will be performed in the Cardiovascular Surgical Intensive Care Unit (CVICU) of the Mazankowski Alberta Heart Institute (MAHI), Alberta Health Services. The proposed trial plans to enroll 100 consecutive eligible patients.
Inclusion:
- Consent (obtained pre-operatively)
- Adult - aged 18 years or older;
- Planned cardiac surgery with CPB;
- Elevated risk for post-operative morbidity, defined by a pre-operative European System for Operative Cardiac Risk Evaluation (EuroSCORE) > 6.
- Able to receive enteral nutrition through nasal/oral gastric or post-pyloric feeding tube.
Exclusion:
- Planned heart or lung transplantation
- Planned cardiac surgery without cardiopulmonary bypass;
- Peri-operative support with extracorporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD).
Study Protocol: Eligible patients will be identified during pre-operative assessment in the pre-operative clinic (PAC). All eligible patients or their surrogate decision-making/legal guardian will then be approached to obtain informed written consent.
Each consenting participant will be randomly allocated (1:1) to receive post-operative enteral glutamine or identical placebo. Investigators, surgeons, intensivists, bedside nurses and participants will remain blinded to study allocation.
Glutamine supplementation will be dosed at 0.5 g/kg satisfactory body weight (SBW)/day divided every 8 hours, starting 6 hours post-operatively and continued for 5 days. The dose of 0.5 g/kg SBW/day was effective in clinical studies using enteral glutamine in critically ill and/or burn injured and major trauma patients. The glutamine supplementation or placebo will be delivered via naso- or oro-gastric feeding tube after confirmation of placement by chest X-ray. For participants who are extubated prior to 5 days, enteral glutamine will be given by mouth for the duration of the 5 day period. Glutamine and placebo will be mixed in orange juice to maintain blinding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Glutamine
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Experimental | Dietary Supplement: GlutamineOral/enteral glutamine 0.5 g/kg satisfactory body weight per day (divided doses every 8 hours) starting 6 hours post-operatively |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinOral/enteral maltodextrin 0.5 g/kg satisfactory body weight per day (divided doses every 8 hours) starting 6 hours post-operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consent (obtained pre-operatively)
- Adult - aged 18 years or older;
- Planned cardiovascular surgery with cardiopulmonary bypass;
- Increased risk for post-operative morbidity, defined by a pre-operative European System for Operative Cardiac Risk Evaluation (EuroSCORE) > 6;
- Able to receive enteral nutrition through nasal/oral gastric or post-pyloric feeding tube.
Key exclusion criteria (3 listed)
- Planned heart or lung transplantation
- Planned cardiovascular surgery without cardiopulmonary bypass;
- Peri-operative support with extracorporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD).
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 |
|---|---|---|
| GlutamineAlso: L-GlutamineEnteric L-Glutamine | Dietary supplement | Glutamine |
| MaltodextrinEnteric Maltodextrin | Dietary supplement | Maltodextrin |
Primary outcome
Proportion of Eligible Patients Providing Consent to Participate
Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Assess the FEASIBILITY of the protocol to (i) achieve >75% consent rate in eligible patients
9 secondary outcomes
Acute Kidney Injury
Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Duration of mechanical ventilation
Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Duration of vasoactive support
Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Blood transfusion
Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Organ Dysfunction Score
Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Adverse events
Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Systemic inflammation
Time frame: Date of surgery until the end of planned study intervention, expected 5-days
Nosocomial infection
Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks
Proportion of Randomized Patients Achieving Protocol Adherence
Time frame: 5-days (date of surgery until the end of planned study intervention)
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 8 Feb 2017.
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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.
Sean Bagshaw principal investigator
University of Alberta
Gurmeet Singh principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutamine and Maltodextrin in people with Nosocomial Infection, run by University of Alberta at 2 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 5 inclusion and 3 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 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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.
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?
Proportion of Eligible Patients Providing Consent to Participate (time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks). 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 8 Feb 2017.