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临床试验/NCT03488940
NCT03488940撤回不适用

Effect of Different Feeding Method on Gastrointestinal Function of Septic Patients (DFM-GF Trial)

Guangdong Provincial Hospital of Traditional Chinese Medicine1 个研究点 分布在 1 个国家开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
The mean time(hours) that reach to the caloric goal in every group.

研究概览

简要总结

The intestine is the most vulnerable target organ in septic patients and is the first to be damaged organ in multiple organ dysfunction syndrome(MODS). Therefore, improving intestinal motility and mucosal barrier function is critical to the treatment of sepsis. Many studies have shown that, early enteral nutrition(EN) in patients with sepsis helps prevent and treat intestinal dysfunction, reducing ICU mortality and length of stay in ICU. However, there is little research on feeding methods. In this study we will compare the outcomes of different feeding methods: continuously-pumped in 24 hours, continuously-pumped in 16 hours and intermittently-pumped through the stomach tube. The aim of this study is to investigate the effects of different feeding methods on intestinal function in septic patients.

详细描述

Sepsis is the major cause of death in intensive care unit(ICU). According to the latest literature statistics in 2012, the mortality of sepsis was growing at 2% a year in the United States, and the average hospitalization costs of septic patients was more than $20000. Sepsis has become one of the big challenges to doctors in ICU all over the world. Previous studies found that intestinal dysfunction may be the main promoter and stimulating factor of systemic inflammatory response syndrome(SIRS), which plays an important role of in the development of sepsis to multiple organ dysfunction syndrome(MODS). But at present there is no effective treatment of intestinal dysfunction. Nutrient intake is considered part of the resuscitation of critical patients. Enteral feedings are considered standard treatment of the critically ill patients. A number of study have found enteral feedings could cure intestine dysfunction through improving circulation perfusion and oxygen delivery, maintaining intestinal mucosal barrier, reconstructing intestinal continuity and adjusting internal environment. Recent clinical researches and guidelines pointed out the importance of early enteral nutrition. However, guidelines made no mention of how to carry on the feeding method in severe patients, and related research is few.The current research mostly thinks, enteral nutrition preparations continuously pumped by stomach tube is a more accepted way.The researches cited by the guideline showed that the continuous feeding was better than that of intermittent feeding. But 24 hours of continuous pumping nutrition preparation will not only cause continuous stimulation to the intestinal mucosa, but also lead to gastrointestinal tract have not rest time. Some previous studies found intermittent feedings were better than continuous feedings to critical patients. So,was intermittent feeding really better? Therefore this research will compare the results of different feeding methods of EN: continuously-pumped in 24 hours, continuously-pumped in 16 hours and intermittently-pumped through the stomach tube. Then observe the effects of different feeding methods on intestinal function in septic patients so as to offer a more suitable EN feeding method for septic patients.

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
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Septic patients in Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine;
  • •APACHE-Ⅱ score greater than 15 points;
  • •Signing the informed consent.

排除标准

  • •Fasting patients in the clinical, such as digestive tract perforation, bleeding or postoperative patients with gastrointestinal tract;
  • •Allergic to enteral nutrition preparations;
  • •Early stage of sepsis (within a week) patients with hemodynamic instability;
  • •Don't want to attend the test or not with the healer.
  • •Fall Off Criteria:
  • •1.Time is less than 7 days in hospital.
  • •Suspension or Termination Criteria:
  • •1.The patients can't tolerate enteral nutrition preparations.

研究组 & 干预措施

24-hours group

Active Comparator

The septic patients randomized to 24-hours group will be received enteral nutrition preparation by 24 hours of continuously pumping through stomach tube every day.

Feeding will be started within 24 hours in admission of ICU. The time of therapy is 7 days.

干预措施: 24-hours group (Device)

16-hours group

Experimental

The septic patients randomized to 16-hours group will be received enteral nutrition preparation by 16 hours of continuously pumping through stomach tube every day.

Feeding will be started within 24 hours in admission of ICU. The time of therapy is 7 days.

干预措施: 16-hours group (Device)

intermittent group

Experimental

The septic patients randomized to intermittent group will be received enteral nutrition preparations by four meals every day(08:00,12:00 18:00,22:00), each meal are pumped within 60mins through stomach tube.

Feeding will be started within 24 hours in admission of ICU. The time of therapy is 7 days.

干预措施: intermittent group (Device)

结局指标

主要结局

The mean time(hours) that reach to the caloric goal in every group.

时间窗: First 7 days after intervention

Caloric goals using 25 kcal/kg (ideal body weight) for caloric need calculated by a single nutritionist.

次要结局

  • Motilin (MTL) (pg/ml)(baseline and 7 days)
  • the rate of new onset pneumonia (%)(First 7 days after intervention)
  • The rate of onset of Gastric residual (%)(First 7 days after intervention)
  • The rate(%) of people whom can reaching the caloric goal.(First 7 days after intervention)
  • Abdominal pressure (mmHg)(baseline and 7 days)

研究者

发起方
Guangdong Provincial Hospital of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guang Yang

Director

Guangdong Provincial Hospital of Traditional Chinese Medicine

研究点 (1)

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