Entral Feeding in Acute Severe Pancreatitis

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

• 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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea
• Intervention / Treatment: Device: nasogastric; Drug: (erythromycin 250 mg IV bolus); Device: nasojejunal

Detailed Description

• 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).

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Saudi Arabia
  • Ta'if, Saudi Arabia, 21944
    • King abd el Aziz specialist hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

• 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.
• An acute physiology and chronic health evaluation (APACHE) II were done for all of them and only score of > 8 included in our study.

Description

Inclusion Criteria:

• acute pancreatitis

Exclusion Criteria:

• systemic disease as hypertension or diabetes

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Group A received nasogastric feeding (NG), insure through ngt pump	Device: nasogastric; • The insertion of NG tubes were performed by the ICU physician and the position was checked by auscultation of gas from 50 ml syringe by injecting 20 ml of air in the NG and by X-ray abdomen to be sure from the site of NG tube; Drug: (erythromycin 250 mg IV bolus); prokinetic (erythromycin 250 mg IV bolus) given to assist the passage of the tube through the pylorus
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	Drug: (erythromycin 250 mg IV bolus); prokinetic (erythromycin 250 mg IV bolus) given to assist the passage of the tube through the pylorus; Device: nasojejunal; The 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of different methods of feeding in the clinical condition of the acute severe pancreatitis	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	13 days

Collaborators and Investigators

• Sponsor: King Abdul Aziz Specialist Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2018
• Primary Completion (Actual): April 2, 2020
• Study Completion (Actual): April 10, 2020

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Pancreatic Diseases; Vomiting; Nausea; Pancreatitis; Postoperative Nausea and Vomiting; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
• Other Study ID Numbers: ICU-28-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes