跳至主要内容
临床试验/CTRI/2024/02/062542
CTRI/2024/02/062542尚未招募2/3 期

Immediate Oral Refeeding Compared to Hunger Based Refeeding and Conventional Oral Refeeding in Patients with Mild and Moderate Acute Pancreatitis - A Multi-Arm Randomized Controlled Trial

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2024年2月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
186
试验地点
1
主要终点
LENGTH OF HOSPITAL STAY

研究概览

简要总结

After obtaining informed consent, the patients with mild and moderate will be randomly allocated to either the IORF, HBORF or CORF group. Patients in the IORF group will be started on a low-fat solid diet immediately upon hospital admission, regardless of symptoms or laboratory parameters. Patients in HBORF group, oral refeeding in the form of oral clear liquid will be commenced once they feel hungry regardless of the pain abdomen and laboratory parameters. For patients in the CORF group, oral diet will be re-introduced in a stepwise manner from fasting, then to clear liquids, and finally, a low-fat solid diet when the patients meet the following criteria: absence of abdominal pain and presence of peristalsis, pancreatic enzymes twofold below the reference limit, blood leukocyte level <15000/mm3, and decreased C-reactive protein level.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Adequate cognitive capacity.

排除标准

  • Severe AP on admission (predicted by presence of SIRS at admission or Patients presenting in shock or sepsis, needing ventilator support).
  • Patients who are unable to undergo USG/CECT within 12hours of admission.

结局指标

主要结局

LENGTH OF HOSPITAL STAY

时间窗: At the time of discharge

次要结局

  • ICU admission/ mortality/ readmission(3 MONTHS)
  • Complications that arise from pancreatitis(30 DAYS)
  • Relapse of abdominal pain(3 MONTHS)
  • Laboratory parameters(AT THE TIME OF ADMISSION)
  • Diet intolerance after starting refeeding(AFTER STARTING FEEDS)
  • Requirement of surgical and non-surgical intervention(3 MONTHS)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Chinthi Reddy Pranaypal Reddy

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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