Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition

Overview

The current study will compare the effectiveness as well as the safety of Itopride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.

Full Title of Study: “The Study of The Efficacy and Safety of Itopride For Feeding Intolerance in Critically-ill Patients Receiving Enteral Nutrition”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2019

Interventions

  • Drug: Itopride
    • Prokinetic Drug
  • Drug: Metoclopramide 10mg
    • Prokinetic Drug

Arms, Groups and Cohorts

  • Active Comparator: First group
    • Metoclopramide 10 mg tablets will be taken by the patients of this group three times daily for 7 days
  • Active Comparator: Second Group
    • Itopride 50 mg tablets will be taken by the patients of this group three times daily for 7 days

Clinical Trial Outcome Measures

Primary Measures

  • Gastric Residual Volume
    • Time Frame: 7 days
    • Gastric residual volume as a surrogate to gastric emptying by means of gastric ultrasound. of the study, at midpoint of the study and at the end of the study by guided ultrasonography.

Secondary Measures

  • Determining the adequacy of enteral nutrition
    • Time Frame: 24 hours
    • By calculating the ratio between administered and prescribed feeds over 24 hours duration (Percentage of feed goal tolerated)
  • Length of ICU stay
    • Time Frame: 3 months
    • Length of patients stay in the ICU will be assessed

Participating in This Clinical Trial

Inclusion Criteria

  • Patients aging between 18 and 60 years (of both sexes) who are admitted to the ICU and are expected to stay in the ICU for not less than 7 days and are prescribed enteral feeding through naso- or oro-gastric tube whose modified nutritional risk in the critically ill (mNUTRIC) score is of more than or equal 5. Exclusion Criteria:

  • Patients who met the following criteria were excluded: – Age less than 18 years or more than 60 years. – Previous upper gastrointestinal tract surgery, obstruction, hemorrhage or history of GI disease. – Clinically significant hepatic dysfunction. (>3 times above the upper end of normal range of bilirubin, γ-glutamyl transferase, aspartate transaminase, or lactate dehydrogenase) – Regular use of H2 blockers, prokinetic, proton pump inhibitor or anticholinergic agents for previous 4 weeks. – Patients with arrhythmia or atrioventricular blocks. – Any condition or comorbid disease that might interfere with gastric emptying such as diabetes. – Patients with head injuries.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eman Mohamed El Mokadem, Assistant Lecturer – Future University in Egypt
  • Overall Contact(s)
    • Eman Elmokadem, MSc., 01006242110, emy_101_@hotmail.com

References

Gholipour Baradari A, Alipour A, Firouzian A, Moarab L, Emami Zeydi A. A Double-Blind Randomized Clinical Trial Comparing the Effect of Neostigmine and Metoclopramide on Gastric Residual Volume of Mechanically Ventilated ICU Patients. Acta Inform Med. 2016 Dec;24(6):385-389. doi: 10.5455/aim.2016.24.385-389.

Gomes PC, Caporossi C, Aguilar-Nascimento JE, Silva AM, Araujo VM. Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers. Arq Gastroenterol. 2017 Jan-Mar;54(1):33-36. doi: 10.1590/S0004-2803.2017v54n1-06.

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