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临床试验/NCT04406506
NCT04406506已完成不适用

Comparative Study Between Different Methods of Enteral Feeding in Acute Severe Pancreatitis

King Abdul Aziz Specialist Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
effect of different methods of feeding in the clinical condition of the acute severe pancreatitis

研究概览

简要总结

• A total of 60 patients admitted to King Abdulaziz Specialists Hospital between June 2018 and April 2020 with both a clinical and biochemical presentation of acute pancreatitis with the following inclusion criteria: Abdominal pain > 6 on the visual analogue scale without given analgesia , abdominal distension and tenderness with serum amylase and serum lipase at least 3 times the upper limit of the reference range (considering normal lipase level from 0-160 U/L, and normal amylase level from 0-100 U/L) with confirmed abdominal computerized axial tomography of grade D and E on Ranson and colleagues criteria(28) of inflamed pancreatic picture.

详细描述

  • The study was conducted on monitoring of four pillar for 13 days (data collected one day before feeding and every three days for 12 days). the first pillar comparing the effect of the two enteral feeding methods on the clinical condition of the acute severe pancreatitis and this monitored clinically and laboratory by fixed parameters, clinically, by abdominal pain which assessed by visual analogue scale (VAS). and laboratory, by both markers of severity of pancreatic acini destruction which assessed by serum amylase, lipase and Markers of severity of interstitial pancreatic tissue destruction which assessed by the level of Lactate Dehydrogenase level (LDH), Aspartate aminotransferase (AST), C-reactive protein, prostacyclin and interleukin 8. The second pillar include effect of the two enteral feeding methods on the patient's tolerance and these monitored in our study by both post-feeding vomiting and post feeding attacks of osmotic diarrhea and also abdominal pain. Third pillar include effect of the two enteral feeding methods on the patient's general condition and these monitored by follows the APACHE II Score, hemodynamics of the patients in both groups (Mean arterial blood pressure and pulse) and arterial oxygen saturation (Spo2). Fourth pillar include effect of the two enteral feeding methods on achieving satisfactory nutrition parameters of the patients and both albumin level, radium blood sugar and electrolytes (sodium and potassium level) used as indicator for this.
  • All parameters observed one day before starting feeding and every 3 days for 12 days (duration of the study).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • acute pancreatitis

排除标准

  • systemic disease as hypertension or diabetes

研究组 & 干预措施

Group A

Group A received nasogastric feeding (NG), insure through ngt pump

干预措施: nasogastric (Device)

Group A

Group A received nasogastric feeding (NG), insure through ngt pump

干预措施: (erythromycin 250 mg IV bolus) (Drug)

Group B

  • receive feeding throughThe nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz.
  • Patients were placed in right lateral position

干预措施: nasojejunal (Device)

Group B

  • receive feeding throughThe nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz.
  • Patients were placed in right lateral position

干预措施: (erythromycin 250 mg IV bolus) (Drug)

结局指标

主要结局

effect of different methods of feeding in the clinical condition of the acute severe pancreatitis

时间窗: 13 days

first pillar comparing the effect of the two enteral feeding methods on the clinical condition of the acute severe pancreatitis,The second pillar include effect of the two enteral feeding methods on the patient's tolerance

次要结局

未报告次要终点

研究者

发起方
King Abdul Aziz Specialist Hospital
申办方类型
Network
责任方
Sponsor

研究点 (1)

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