Evaluations the Effect of Parenteral Glutamine on Reducing Infection Morbidity in Burn Patients in ICU. A Randomized Controlled Double-blind Study.
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- wound culture test
研究概览
简要总结
The study is designed to evaluate the effect of parenteral glutamine supplementation on infection in burn patients.
详细描述
Despite improvements in prevention and management, burn injury continues to represent a major threat to the health and welfare of people worldwide in all age groups. Even with early surgical intervention and aggressive antibiotic therapy, infectious complications are a major cause of death in severe burn injury, accounting for 75% of all deaths occurring after initial resuscitation.
It is proposed that one source of these infections is a translocation of gram-negative bacteria from the gut. However, this mechanism of bacterial translocation through the gut wall remains a controversial mechanism of infection in humans. In animal studies, it has been demonstrated that glutamine supplementation can decrease gut-derived bacterial translocation and improve outcomes from burn injury.
Whether this holds true in humans has to be evaluated by additional studies. A recent study concluded that glutamine supplementation reduces gram-negative bacteremia in burned patients but viewed itself as preliminary and suggested that more clinical trials are warranted to corroborate the study outcome.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-50 years.
- •Total burn surface area of 20% - 60%.
- •Expected length of stay in ICU > 48 hr.
- •Admission within 72 hrs of burn injury.
- •Any thermal injury such as flame burns. Scald burns and contact burns.
排除标准
- •Burn patients with hepatic failure.
- •Burn patient with Severe renal failure (glomerular filtration rate (eGFR <50 ml/min).
- •Patients with inborn errors of amino-acid metabolism (e.g., phenylketonuria).
- •Burn patients with pre-existing severe cardiac, pulmonary diseases.
- •Burn patients with diabetes mellitus or cancer.
- •Patients with metabolic acidosis (pH<7.35).
- •Electric burns.
研究组 & 干预措施
group I
Patient were received 0.5gm/kg/day IV glutamine infusion (dipeptiven 100ml contains 20 g N(2)-L-alanyl-L-glutamine (= 8.20 g L-alanine, 13.46 g L-glutamine) Water for Injections).
干预措施: Dipeptiven (Drug)
group II
Patients received an equivalent volume of normal saline daily for 7 days.
干预措施: normal Saline (Drug)
结局指标
主要结局
wound culture test
时间窗: on 1,5,10 and 15 days after ICU admission
whether +ve or -ve test
次要结局
- Procalcitonin level(on 1,5,10 and 15 days after ICU admission)
- CRP(on 1,5,10 and 15 days after ICU admission)
研究者
ashraf magdy eskandr
assistant professor of anesthesia
Menoufia University