ISRCTN92905442已完成未知
Effects of enteral glutamine supplementation on mortality and infectious morbidity in severely burned patients: a multicentre randomised double blind controlled trial
Clinical Evaluation Research Unit (CERU) (Canada)0 个研究点目标入组 200 人开始时间: 2010年1月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29799545 [added 13/03/2019]
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 21/03/2012
- •1. Total Burn Surface Area (TBSA):
- •TBSA = 20% for patients ages 18 - 59 years OR
- •TBSA = 10% for patients ages 60 - 80 years
- •2. Deep 2nd and/or 3rd degree burns requiring grafting
- •3. Age + TBSA = 40-119
- •Previous inclusion criteria
- •1. Age + total burn surface area (TBSA) = 60 - 120 (upper limit not included)
- •2. Deep 2nd and/or 3rd degree burns
- •3. TBSA greater than or equal to 20%
排除标准
- •Current exclusion criteria as of 21/03/2012
- •1. > 72 hrs from admission to ICU to time of consent
- •2. Patients > 80 yrs or < 18 yrs of age
- •3. Liver cirrhosis - Child s class C liver disease
- •4. Pregnancy
- •5. Absolute contra-indication for EN (intestinal occlusion or perforation, abdominal injury)
- •6. Patients admitted > 48 hrs post burn (for patients that receive standardized burn care and resuscitation
- •prior to admission to ICU, this exclusion criteria may be extended to ?Patients admitted > 96 hrs post
- •burn; if this is the case consent must be obtained within 24 hrs of admission to burn ICU according to
- •the judgement of the Site Investigator)
- •7. Patients with injuries from high voltage electrical shock
- •8. Patients who are moribund
- •9. Patients with BMI < 18 or > 50
- •10. Enrollment in another industry sponsored ICU intervention study (co-enrollment in academic studies will
- •be considered on a case by case basis)
- •11. Received glutamine supplement for > 24 hrs prior to randomization
- •12. Known allergy to maltodextrin, corn starch, corn, or corn products
- •Previous exclusion criteria
- •1. Greater than 48 hours from admission to intensive care unit (ICU) to time of consent
- •2. Patients older than 80 years or younger than 18 years of age (age of maturity for an eligible patient to obtain consent is 18 years in Canada and in the United States of America)
- •3. Liver cirrhosis: Child's class C liver disease
- •4. Pregnancy (urine/blood tests for pregnancy will be done on all women of childbearing age by each site as part of standard of ICU practice)
- •5. Associated multiple fractures or severe head trauma
- •6. Absolute contra-indication for enteral nutrition (EN): intestinal occlusion or perforation, abdominal injury
- •7. Patients admitted more than 48 hours post-burn (for patients that receive standardised burn care and resuscitation prior to admission to ICU, this exclusion criteria may be extended to Patients admitted more than more than 72 hours post-burn according to the judgement of the Site Investigator)
- •8. Patients with injuries from high voltage electrical shock
- •9. Patients who are moribund
- •10. Patients with extreme body sizes: body mass index (BMI) less than 18 or greater than 50 kg/m^2
- •11. Enrolment in another industry sponsored ICU intervention study (co-enrolment in academic studies will be considered on a case by case basis)
研究者
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