Entral Feeding in Acute Severe Pancreatitis

Sponsor
King Abdul Aziz Specialist Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04406506
Collaborator
(none)
60
1
22
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: nasogastric
  • Device: nasojejunal
  • Drug: (erythromycin 250 mg IV bolus)

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparative Study Between Different Methods of Enteral Feeding in Acute Severe Pancreatitis
Actual Study Start Date :
Jun 10, 2018
Actual Primary Completion Date :
Apr 2, 2020
Actual Study Completion Date :
Apr 10, 2020

Arms and Interventions

Arm 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

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • acute pancreatitis
Exclusion Criteria:
  • systemic disease as hypertension or diabetes

Contacts and Locations

Locations

Site City State Country Postal Code
1 King abd el Aziz specialist hospital Ta'if Saudi Arabia 21944

Sponsors and Collaborators

  • King Abdul Aziz Specialist Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
King Abdul Aziz Specialist Hospital
ClinicalTrials.gov Identifier:
NCT04406506
Other Study ID Numbers:
  • ICU-28-20
First Posted:
May 28, 2020
Last Update Posted:
May 28, 2020
Last Verified:
May 1, 2020
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 28, 2020