Trial reportBMC gastroenterology2021
The efficacy and safety of itopride in feeding intolerance of critically ill patients receiving enteral nutrition: a randomized, double-blind study.
Trial report in BMC gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03698292 (The Study of The Efficacy and Safety of Itopride For Feeding Intolerance in Critically-ill Patients Receiving Enteral Nutrition), which is not on this map. Cited by 8 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Study of The Efficacy and Safety of Itopride For Feeding Intolerance in Critically-ill Patients Receiving Enteral Nutrition
Who cites it
8 citing papers in PubMed, 20 citations in OpenAlex.
- Application of Touching Combined with Intelligent Interaction of Voice and Rhythm in Nursing Care of Newborns with Feeding Intolerance and Its Influence on Quality of Life.Computational and mathematical methods in medicine · 2022Trial
- Risk prediction models for enteral nutrition feeding intolerance in critically ill patients: an overview of systematic reviews.Frontiers in nutrition · 2025Review
- Analysis of outcome indicators in clinical trials related to feeding intolerance in ICU patients receiving enteral nutrition feeding.Frontiers in nutrition · 2025Article
- Feeding Intolerance-A Key Factor in the Management of Acute Pancreatitis: A Review.Journal of clinical medicine · 2024Review
- Research progress on digestive disorders following traumatic brain injury.Frontiers in immunology · 2024Review
- Comparison of enteral prucaloprideFrontiers in pharmacology · 2024Article
- Prediction of prokinetic agents in critically ill patients with feeding intolerance: a prospective observational clinical study.Frontiers in nutrition · 2023Article
- Gastric ultrasound for feeding intolerance in the ICU: close but not quite right.BMC gastroenterology · 2022Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEnteral feeding intolerance (EFI) is a frequent problem in the Intensive care unit (ICU) and is associated with poor clinical outcomes leading to worse prognosis in terms of mortality and ICU stay. Nowadays, prokinetic drugs are the mainstay of therapy in EFI. However, available prokinetics have uncertain efficacy and safety profiles. Itopride, is a prokinetic agent which is different and unique from the available prokinetics because of its dual mode of action as well as its tolerability and safety. The current study compared the efficacy and safety of Itopride against metoclopramide for EFI in critically ill patients. Moreover, it tested the utility and applicability of ultrasonography to measure gastric residual volume (GRV) in this population.
methodsThis randomized, double-blind study included 76 EFI patients who were randomly assigned to either Itopride or metoclopramide group. The primary outcome was to measure GRV by ultrasonography. Secondary outcomes included the percentage ratio of enteral feed volume, energy and protein received by patients over 7 days of treatment, ICU length of stay, safety parameters and occurrence of infectious complications or vomiting.
resultsThirty-five patients of each group completed the study. At day 7, itopride significantly decreased GRV compared with metoclopramide group (p = 0.001). Moreover, there was a significant increase in the ratios of received enteral nutrition feed volume, calories, and protein after the one-week therapy in the itopride group more than the metoclopramide group (p = 0.001), (p = 0.002), (p = 0.01), respectively and there were no differences in any secondary outcomes or adverse events between the two groups.
conclusionIn critically ill patients with EFI, itopride was well tolerated with superior efficacy to metoclopramide. In addition, we demonstrated that ultrasonography is a simple, non-invasive, inexpensive, and undemanding method for GRV measurements and can offer reliable assessments in the gastric emptying modality.
trial registrationThe trial was registered in ClinicalTrials.gov (NCT03698292). Date: October 5, 2018.
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