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Completed

NCT Number: NCT01704430

Glutamine to Improve Outcomes in Cardiac Surgery

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.

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Key information

Conditions

Nosocomial Infection Cross Infection Disease Attributes Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Glutamine

Dietary Supplement

Enteric L-Glutamine

Other names: L-Glutamine

Maltodextrin

Dietary Supplement

Enteric Maltodextrin

Primary outcomes

  1. 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

Secondary outcomes

  1. Acute Kidney Injury

    Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks

  2. Duration of mechanical ventilation

    Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks

  3. Duration of vasoactive support

    Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks

  4. Blood transfusion

    Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks

  5. Organ Dysfunction Score

    Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks

    Post-operative changes to the Sequential Organ Failure Assessment score

  6. Adverse events

    Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks

    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

  7. Systemic inflammation

    Time frame: Date of surgery until the end of planned study intervention, expected 5-days

    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).

  8. Nosocomial infection

    Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks

    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.

  9. Proportion of Randomized Patients Achieving Protocol Adherence

    Time frame: 5-days (date of surgery until the end of planned study intervention)

    Obtain > 90% protocol adherence

Other outcomes

  1. Mortality

    Time frame: From the Date of Surgery until Date of Death or 90-days, whichever occurs first

  2. Duration of ICU stay

    Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks

  3. Duration of hospital stay

    Time frame: Date of surgery until date of hospital discharge, an expected average of 2 weeks

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

GLutamine Enterally After carDiac Surgery for Inflammation Attenuation and ouTcOme impRovement (GLADIATOR): A Phase II Randomized, Blinded, Placebo-Controlled Trial

Acronym: GLADIATOR

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 11, 2012
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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