GLutamine Enterally After carDiac Surgery for Inflammation Attenuation and ouTcOme impRovement (GLADIATOR): A Phase II Randomized, Blinded, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Proportion of Eligible Patients Providing Consent to Participate
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Proportion of Eligible Patients Providing Consent to Participate
时间窗: 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
次要结局
- Acute Kidney Injury(Date of surgery until date of hospital discharge, an expected average of 2 weeks)
- Duration of mechanical ventilation(Date of surgery until date of hospital discharge, an expected average of 2 weeks)
- Duration of vasoactive support(Date of surgery until date of hospital discharge, an expected average of 2 weeks)
- Blood transfusion(Date of surgery until date of hospital discharge, an expected average of 2 weeks)
- Organ Dysfunction Score(Date of surgery until date of hospital discharge, an expected average of 2 weeks)
- Adverse events(Date of surgery until date of hospital discharge, an expected average of 2 weeks)
- Systemic inflammation(Date of surgery until the end of planned study intervention, expected 5-days)
- Nosocomial infection(Date of surgery until date of hospital discharge, an expected average of 2 weeks)
- Proportion of Randomized Patients Achieving Protocol Adherence(5-days (date of surgery until the end of planned study intervention))