跳至主要内容
临床试验/CTRI/2024/07/071278
CTRI/2024/07/071278尚未招募2 期

Continuous versus intermittent enteral tube feeding for critically ill patients A prospective randomized comparative trial

Fortis Escorts hospital Jaipur1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
The primary outcome will be Mean duration to achieve at least 70% of the target nutrition requirement after the start of enteral feeding(in hours). The achievement rate will be calculated as the number of days in which at least 70% of the target nutrition requirement is achieved divided by the total number of days of feeding days. Gastrointestinal intolerance during the first 7 days after the start of enteral feeding

研究概览

简要总结

NUTRITION IS IMPORTANT PART FOR TREATMENT OF CRITICALLY ILL PATIENTS.METHOD OF NUTRITION IN CRITICALLY ILL PATIENTS IS ALWAYS DEBATABLE.ENTRTAL FEEDINF IS PREFFERED OVER PARENTERAL FEEDING.IN ENTERAL FEEDING INTERMITTENT FEEDING IS MORE PHYSIOLOGICAL BUT CONTINUOUS FEEDING MAY BE MORE TOLERABLE.IN INDIA THERE HAS NOT BEEN ANY STUDY TO PROVE THIS.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Adult patients 18 to 80 years admitted to the intensive care unit (MEDICAL ICU) 2.Patients receiving mechanical ventilation,who expected to require ventilation for greater than or equal to72 hrs and where to start enteral tube feeding with in 48 hrs of the icu admission.
  • 3.Hemodynamically stable patients.
  • 4.BMI is 18 to 50 5.Patient’s relative giving consent.

排除标准

  • 1.Patients with contraindications to enteral feeding, such as severe diarrhea greater than one litre in 24hrs,acute pancreatitis,bowel ischemia,bowel obstruction,history of upper GI surgery,malabsorption syndrome,GI bleeding,short bowel syndrome.
  • 2.Pregnancy or lactation.
  • 3.Presence of a percutaneous endoscopic gastrostomy (PEG) or jejunostomy tube.
  • 4.Anticipated need for surgical intervention during the study period.
  • 5.Hypersensitivity reactions to prokinetic agents 6.Abdominal surgery with in one month.
  • 7.Difficulty in placement of nasogastric or orogastric tube.
  • 8.Ongoing enteral nutrition on admission to MICU.
  • 9.Patient’s relatives not giving consent.

结局指标

主要结局

The primary outcome will be Mean duration to achieve at least 70% of the target nutrition requirement after the start of enteral feeding(in hours). The achievement rate will be calculated as the number of days in which at least 70% of the target nutrition requirement is achieved divided by the total number of days of feeding days. Gastrointestinal intolerance during the first 7 days after the start of enteral feeding

时间窗: Enteral feeding will be initiated with in 48 hours of ICU admission after randomization.Target nutrition will be achieved as early as possible and study will monitor patient for seven days for target achieved.

次要结局

  • Secondary endpoints will include ICU mortality, 28-day mortality, length of stay in the ICU and hospital(Secondary endpoints will include ICU mortality, 28-day mortality, length of stay in the ICU and hospital)

研究者

发起方
Fortis Escorts hospital Jaipur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Bhupendra kumar tiwari

FORTIS ESCORTS HOSPITAL,JAIPUR

研究点 (1)

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