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临床试验/NCT02370030
NCT02370030Unknown1 期

Controlled Randomized Multi-centric Clinical Trial on the Effect of Citrulline on the Clinical and Biochemical Evolution of Patients With Sepsis.

Instituto Mexicano del Seguro Social2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
160
试验地点
2
主要终点
Multiple organ failure

研究概览

简要总结

Triple blind placebo-controlled study to determine if administering citrulline in patients with sepsis and severe sepsis slows progression to multiple organ failure and death, measuring biomarkers of endothelial dysfunction. Patients are divided into placebo or citrulline and followed up for 1 month.

详细描述

Consecutive patients with sepsis are being recited from intensive care unite of IMSS at the CMN Siglo XXI and CMN La Raza over the period of november 2015 through june 2016. After signing an informed consent they will be randomized into 80 for intervention arm and 80 for the placebo arm. All patients will receive usual medical treatment; and during seven days citurlline arm subjects will receive supplementation with oral or nasogastric citrulline (10 g/day), while other group patients will receive during seven days oral or nasogastric placebo (10 g/day) with no visible difference between these. Microalbuminuria and interleukines 1, 6, and 10 will be measured at randomization and at day 7. All subjects will be followed for 28 days, and after the follow-up period results will be analyzed to determine de efficacy and safety of citrulline, primary outcome are the incidence of multiple organic failure and death, also microalbuminuria levels 1,6,10-interleukines. We will use Student-t and Chi2 for statistical analysis.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Severe sepsis
  • •Diagnosis of sepsis in the first 36 hours of hospitalization.
  • •Informed Consent
  • •Intestinal tract intact

排除标准

  • •Terminal cancer
  • •Acute and chronic liver diseases
  • •Chronic renal failure.
  • •Acute renal failure AKIN III.
  • •Pregnant and postpartum women
  • •Dying patients.
  • •Patients with cardiac arrest.
  • •Active gastrointestinal bleeding.
  • •Steroids or immunosuppressants.
  • •Enrolled in another study intervention.
  • •Citrulline allergy.

研究组 & 干预措施

Intervention

Active Comparator

Oral or nasogastric administration of 10 g citrulline malate daily. Blood and urine samples to determine biomarkers of endothelial damage (IL 6, IL 10 , nitric oxide and microalbuminuria), with a second sampling after 7 days of intervention. Disease severity will be measure with various scales, including APACHE II, SOFA

干预措施: Citrulline malate (Dietary Supplement)

Placebo

Placebo Comparator

10 g of maltodextrin will be substituted for the citrulline. Blood and urine samples to determine biomarkers of endothelial damage (IL 6, IL 10 , nitric oxide and microalbuminuria), with a second sampling after 7 days of intervention. Disease severity will be measure with various scales, including APACHE II, SOFA

干预措施: Citrulline malate (Dietary Supplement)

结局指标

主要结局

Multiple organ failure

时间窗: 1 month

Progression to multiple organ failure ending in death

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eduardo Almeida Gutiérrez

Head Researcher

Instituto Mexicano del Seguro Social

研究点 (2)

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