A Phase 1/2 interventional study of Prucalopride and Metoclopramide in Enteral Feeding Intolerance, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Ain Shams University · Phase 1/2, Interventional, and Treatment
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.
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who met the following criteria were excluded:
Patients will receive prucalopride (2 mg) once daily for 7 days.
Drug: Prucalopride
Patients will receive metoclopramide (10 mg) three times daily for 7 days.
Drug: Metoclopramide
Prokinetic
Also known as: Resolor
Prokinetic
Also known as: Primperan
Gastric residual volume
Gastric residual volume as a surrogate to gastric emptying by means of gastric residual volume
Time frame: 7 days
Determining the adequacy of enteral nutrition:
Enteral nutrition volume ratio
Time frame: 7 days
Incidence of infectious complications.
C reactive protein
Time frame: one month
Length of ICU stay
duration of stay in intensive care unit
Time frame: 3 months
Adverse drug events
occurence of adverse drug events
Time frame: 7 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Ain Shams University