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Paralytic ileus is a common intestinal dysfunction in critically ill patients. There are still no established the effective medications except correcting the primary causes and prokinetics trial which limited in efficacy and potential adverse events.
Prucalopride, a highly selective 5-HT4 receptor agonist, accelerates gastrointestinal transit which may reduce severity of ileus. Furthermore, there is no report of serious cardiac and neurological side effects. We aim to evaluate the efficacy of prucalopride as a prokinetic of choice on paralytic ileus in critically ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prucalopride | Experimental | Prucalopride (Trade name: Resolor) 2 mg oral or tube feeding once daily 5 consecutive days Decrease dose to 1 mg once daily in patient with end stage kidney disease or Cirrhosis Child Pugh C |
|
| Placebo | Placebo Comparator | Placebo tablet to mimic Prucalopride made by starch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prucalopride | Drug | 1-2 mg once daily enteral feeding for 5 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of maximum bowel diameter from baseline at 24 hours | measure on plain abdominal radiography by blinded radiologist | after first dose intervention to next 24 hours |
| Change of maximum bowel diameter from baseline at 48 hours | measure on plain abdominal radiography by blinded radiologist | after first dose intervention to next 48 hours |
| Change of maximum bowel diameter from baseline at 72 hours | measure on plain abdominal radiography by blinded radiologist | after first dose intervention to next 72 hours |
| Change of maximum bowel diameter from baseline at 96 hours | measure on plain abdominal radiography by blinded radiologist | after first dose intervention to next 96 hours |
| Change of maximum bowel diameter from baseline at 120 hours | measure on plain abdominal radiography by blinded radiologist | after first dose intervention to next 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| change of abdominal circumference from baseline at 24 hours | measured at umbilical level | after first dose intervention to next 24 hours |
| change of abdominal circumference from baseline at 48 hours |
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Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Panu Wetwittayakhlang, Dr. | Contact | 66867725277 | wet.panu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sawangpong Jandee, Dr. | Faculty of Medicine, Prince of Songkla University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Prince of Songkla University | Recruiting | Songkhla | 90110 | Thailand |
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| ID | Term |
|---|---|
| D007418 | Intestinal Pseudo-Obstruction |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D045823 | Ileus |
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C406662 | prucalopride |
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Consecutive enrolment parallel group in intervention group and placebo group
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The intervention was blinded to patients, nurse, investigators, and radiologist
| Placebo | Drug | 1/2-1 tablet once daily enteral feeding for 5 consecutive days |
|
measured at umbilical level
| after first dose intervention to next 48 hours |
| change of abdominal circumference from baseline at 72 hours | measured at umbilical level | after first dose intervention to next 72 hours |
| change of abdominal circumference from baseline at 96 hours | measured at umbilical level | after first dose intervention to next 96 hours |
| change of abdominal circumference from baseline at 120 hours | measured at umbilical level | after first dose intervention to next 120 hours |
| D004066 |
| Digestive System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |