The Effect of Enteral Glutamine and Vitamin C Supplementation on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients: A Prospective, Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Interleukin-6
研究概览
简要总结
Background & Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementations of glutamine and vitamin C potentially have beneficial effects on wound healing and a reduction in infection rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in proinflammatory cytokines and clinical outcomes were investigated.
详细描述
Background & Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementation of glutamine in ICU patients has been under much debate. Another nutritional supplement, vitamin C, had a beneficial effect on wound healing and a reduction in infection rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in proinflammatory cytokines and clinical outcomes were investigated.
Methods. This is a prospective double-blind randomized study for surgical ICU patients whom can sustain enteral feeding. The test group was provided with glutamine and vitamin C (the GA group); the control (C) group was provided with maltodextrin of equivalent calories as that provided in the GA group. Plasma glutamine, interleukin-6 (IL-6), and clinical data were collected and analyzed with biostatistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a prospective double-blind randomized study for surgical ICU patients whom can sustain enteral feeding. The test group was provided with glutamine and vitamin C (the GA group); the control (C) group was provided with maltodextrin of equivalent calories as that provided in the GA group.
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages 20 and 85 years
- •Not enrolled in other clinical trials in the previous 1 month and during the study period
- •Surgical ICU patients cared by the 9 participating surgeons
排除标准
- •Older than age 85 years
- •Pregnant women
- •With an abnormal liver function (receiving drugs or clinical therapies)
- •Abnormal renal function (under hemodialysis)
- •Multiple organ failure (more than 2 organs)
- •Expected ICU stay of less than 72 hours
结局指标
主要结局
Interleukin-6
时间窗: Blood samples were collected for biochemical analyses on the starting day of enteral feeding (day of enrollment), and every 7 days until day of discharge from ICU, or on the day of discharge from ICU, which ever is shorter, assessed up to 14 days.
Blood samples were collected for biochemical on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU.
Body mass index (BMI)
时间窗: At enrollment.
body height and weight were taken and body mass index (BMI) calculated at baseline.
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
时间窗: At enrollment.
APACHE II score was calculated to classify the disease severity.
C reactive protein
时间窗: On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Hematological analyses
Interleukin-10
时间窗: Blood samples were collected for biochemical analyses on the starting day of enteral feeding (day of enrollment), and every 7 days until day of discharge from ICU, or on the day of discharge from ICU, which ever is shorter, assessed up to 14 days.
Blood samples were collected for biochemical on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU.
Plasma glutamine
时间窗: Blood samples were collected for biochemical analyses on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Blood was collected for analyses of plasma glutamine levels
Red blood cells
时间窗: On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Blood was collected for hematological analyses
Hemoglobin
时间窗: On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Blood was collected for hematological analyses
White blood cells
时间窗: On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.
Hematological analyses
次要结局
- Mortality in hospital stay(Up to one year)
- Length of ICU stay(Up to one year)
- Duration of ventilator use(Up to one year)
- ICU infectious complications(Up to one year)
- Mortality in ICU stay(Up to one year)
- Length of hospital stay(Up to one year)
研究者
Frank Lin, MD, PhD
Department Chairman
Chung Shan Medical University