Entral Feeding in Acute Severe Pancreatitis

NCT04406506 | Completed FDA Drug

• 1 other identifier: ICU-28-20
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Postoperative Nausea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A

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

Device: nasogastric; Drug: (erythromycin 250 mg IV bolus)

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

Device: nasojejunal; Drug: (erythromycin 250 mg IV bolus)

Interventions

nasogastric DEVICE

• 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

Group A

nasojejunal DEVICE

* 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

Group B

(erythromycin 250 mg IV bolus) DRUG

prokinetic (erythromycin 250 mg IV bolus) given to assist the passage of the tube through the pylorus

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• acute pancreatitis

You may not qualify if:

• systemic disease as hypertension or diabetes

Sponsors & Collaborators

• King Abdul Aziz Specialist Hospital: lead

Study Sites (1)

King abd el Aziz specialist hospital

Ta'if, 21944, Saudi Arabia

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Intubation, Gastrointestinal; Erythromycin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Intubation; Therapeutics; Investigative Techniques; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 13 Days
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 28, 2020
• Study Start: June 10, 2018
• Primary Completion: April 2, 2020
• Study Completion: April 10, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

SA (1)