A Randomized Controlled Trial of Glutamine Supplementation in Critically Ill Adults With Severe Sepsis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Severe sepsis is a common condition with high mortality and morbidity. A previous meta-analysis has demonstrated the safety of glutamine supplementation with suggestion of mortality and morbidity benefits in critically ill patients. But there is lack of evidence to recommend the use of intravenous glutamine supplementation in this population group. A randomized controlled trial which is adequately powered will resolve this issue and can be included in future international nutrition guidelines for the critically ill. This pilot study is done prior to a proposed local multi-center study to investigate the effects of glutamine supplementation.
详细描述
Objective
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To determine the effect of intravenous glutamine supplementation compared with placebo in critically ill patients with severe sepsis
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Primary outcome : 28 day mortality , Development of infectious complications
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Secondary outcomes
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Duration of mechanical ventilation
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Length of stay in ICU
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Length of stay in hospital
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3 month survival status and resumption of baseline activities
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6 month survival status and resumption of baseline activities
Study Design
- Single center, prospective, double blind, randomised controlled trial critically ill patients with severe sepsis
- Randomisation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* All adult patients (\>18 years old) admitted to ICU plus
- •* Severe sepsis defined as 2 or more or the following
- •* Temperature \>38oC or \< 36oC
- •* Heart rate \> 90 beats per min
- •* Respiratory rate \>20 breaths per min or PaCO2 \<32 mmHg
- •* White cell count \> 12,000/microL or \< 4,000/microL
- •* PLUS presence or presumed presence of infection
- •* PLUS evidence of organ dysfunction as defined by either of the following
- •* Hemodynamic: Hypotension = systolic blood pressure (SBP) 40 mm Hg or mean arterial pressure (MAP) \< 65 mm Hg; or on vasopressors
- •* Hyperlactatemia: Serum lactate \>/= 2 mmol/L (18 mg/dL)
- •* Renal: Acute increase in serum creatinine to \> 176.8 mmol/L (2.0 mg/dL) or urine output \< 0.5 mL/kg/hour for \> 2 hours
- •* Lung: Acute lung injury with PaO2/FiO2 \/= 34.2 umol/L (2 mg/dL)
- •* Thrombocytopenia: Acute decrease in platelet count to \< 100,000 cells/mm3
- •* Coagulopathy: International normalized ratio (INR) \> 1.5 or a partial thromboplastin time (aPTT) \> 60 secs which is not due to anticoagulant therapy
排除标准
- •>48hr from admission to ICU
- •Patients who are not expected to survive >48hrs by the managing team
- •Refusal to consent to study
- •Allergic to glutamine or its constituents
- •Absolute contraindication to enteral nutrition or the need to initiate parenteral nutrition
- •Patients with a primary admission diagnosis of burns (>30% body surface area)
- •Patients whose weight <40kg or >200kg
- •Previous randomization to this study
- •Enrolled in a related ICU interventional nutrition study
- •Pregnant patients or lactating mothers with the intent to breastfeed
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Dietary Supplement)
Glutamine
Glutamine
干预措施: Glutamine (Dietary Supplement)
结局指标
主要结局
Mortality
时间窗: 28 day
次要结局
- ICU length of stay (LOS)(From date of ICU admission to date of transferred to General Ward or date of death from any cause, whichever came first, assessed up to 21 days.)
- Hospital LOS(From date of recruitment to date of discharged from hospital or date of transferred to other hospitals or date of death from any cause, whichever came first, assessed up to 130 days.)
- Occurrence of new infections(Initial hospital admission, assessed up to 130 days.)
- Duration of mechanical ventilation(During period of ICU stay, assessed up to 14 days.)