Critically-ill Patients Clinical Trial
Official title:
The Study of The Efficacy and Safety of Itopride For Feeding Intolerance in Critically-ill Patients Receiving Enteral Nutrition
| NCT number | NCT03698292 |
| Other study ID # | 67 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2018 |
| Est. completion date | September 2019 |
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | September 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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, ?-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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Kasr Al Ainy Hospital | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Ain Shams University |
Egypt,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Length of ICU stay | Length of patients stay in the ICU will be assessed | 3 months |