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

Study Overview
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Brief Summary
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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.

Official Title
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The Study of The Efficacy and Safety of Itopride For Feeding Intolerance in Critically-ill Patients Receiving Enteral Nutrition

Conditions
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Critically-ill Patients

Intervention / Treatment
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* Drug: Itopride
* Drug: Metoclopramide 10mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First group<br>Metoclopramide 10 mg tablets will be taken by the patients of this group three times daily for 7 days | Drug: Metoclopramide 10mg<br>* Prokinetic Drug<br>|
| Active Comparator: Second Group<br>Itopride 50 mg tablets will be taken by the patients of this group three times daily for 7 days | Drug: Itopride<br>* Prokinetic Drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric Residual Volume | 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. | 7 days | 

Secondary Outcome Measures

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