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| Name | Class |
|---|---|
| Future University in Egypt | OTHER |
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to compare the effectiveness as well as the safety of prucalopride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.
Provision of nutrition support to the critically ill is now established as an essential part of patient care where aiming toward 100% of the predicted target may have resulted in reduced mortality and increased ventilator-free days in those who are premorbidly malnourished. Despite these reported benefits, clinicians continue to deliver little more than half of the enteral nutrition (EN) they plan to provide, due to gastric motility disorders, patient intolerance and clinical interruptions. Also despite the availability of numerous clinical practice guidelines (CPGs) focused on feeding critically ill patients, observational studies have consistently demonstrated persistent and significant gaps between guideline recommendations and actual nutrition practice. Consequently, underfeeding is prevalent in the intensive care unit (ICU), with patients on average receiving only 60 % of the calories that are prescribed. Moreover, Among the barriers to adequate nutritional supply in the ICU which contributes to nutritional status deterioration, gastrointestinal disorders causing enteral feed intolerance are the most important and the most often mentioned in the literature. when gastric emptying was measured in critically ill patients, 46 % of them had evidence of delayed gastric emptying. Untreated slow gastric emptying has a plethora of clinical consequences such as vomiting, aspiration of gastric contents, pneumonia, and contributes significantly to the frequent interruptions and cessation of EN in the ICU, which results in inadequate nutritional delivery. Studies have shown an association between feeding intolerance, prolonged intensive care unit (ICU) stay, and increased risk of death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prucalopride | Active Comparator | Patients will receive prucalopride (2 mg) once daily for 7 days. |
|
| Metoclopramide | Active Comparator | Patients will receive metoclopramide (10 mg) three times daily for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prucalopride | Drug | Prokinetic |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric residual volume | Gastric residual volume as a surrogate to gastric emptying by means of gastric residual volume | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Determining the adequacy of enteral nutrition: | Enteral nutrition volume ratio | 7 days |
| Incidence of infectious complications. | C reactive protein |
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Inclusion Criteria:
Exclusion Criteria:
Patients who met the following criteria were excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Eman Elmokadem, PhD | Future University in Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al Ainy Hospital | Cairo | 11865 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39584139 | Derived | Elmokadem EM, Abou El Fadl DK, Eissa N, Alnassar NA, Bassiouny AM, Hanna Samy AE, El Said NO. Comparison of enteral prucalopride versus intravenous metoclopramide for feeding intolerance in patients with critical illness: a randomized double-blinded study. Front Pharmacol. 2024 Nov 8;15:1413246. doi: 10.3389/fphar.2024.1413246. eCollection 2024. |
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| ID | Term |
|---|---|
| C406662 | prucalopride |
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Metoclopramide |
| Drug |
Prokinetic |
|
|
| one month |
| Length of ICU stay | duration of stay in intensive care unit | 3 months |
| Adverse drug events | occurence of adverse drug events | 7 days |
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |