Nosocomial Infection Clinical Trial
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.
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.
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