Clinical trial NCT03698292: Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition
Official title: The Study of The Efficacy and Safety of Itopride For Feeding Intolerance in Critically-ill Patients Receiving Enteral Nutrition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critically-ill Patients
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gastric Residual Volume
timeFrame: 7 days
Secondary outcomes:
measure: Determining the adequacy of enteral nutrition
timeFrame: 24 hours
measure: Length of ICU stay
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: Elmokadem EM, El Borolossy RM, Bassiouny AM, Hanna MG, Darweesh EAG, Sabri NA. The efficacy and safety of itopride in feeding intolerance of critically ill patients receiving enteral nutrition: a randomized, double-blind study. BMC Gastroenterol. 2021 Mar 19;21(1):126. doi: 10.1186/s12876-021-01712-w.