Critically Ill Clinical Trial
— EPRUCILOfficial title:
Efficacy of Prucalopride in Critically Ill Patients With Paralytic Ileus; a Pilot Randomized Double-blind Controlled Trial
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.
Status | Recruiting |
Enrollment | 62 |
Est. completion date | February 15, 2020 |
Est. primary completion date | January 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion: - Medical patients with APACHE II score >= 15 - Paralytic ileus: small bowel diameter >= 4 cm or large bowel diameter >= 6 cm Exclusion: - no current prokinetic use - Severe peritonitis or bowel inflammation - ESRD needed hemodialysis |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine, Prince of Songkla University | Songkhla |
Lead Sponsor | Collaborator |
---|---|
Prince of Songkla University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | change of abdominal circumference from baseline at 24 hours | measured at umbilical level | after first dose intervention to next 24 hours | |
Secondary | change of abdominal circumference from baseline at 48 hours | measured at umbilical level | after first dose intervention to next 48 hours | |
Secondary | change of abdominal circumference from baseline at 72 hours | measured at umbilical level | after first dose intervention to next 72 hours | |
Secondary | change of abdominal circumference from baseline at 96 hours | measured at umbilical level | after first dose intervention to next 96 hours | |
Secondary | change of abdominal circumference from baseline at 120 hours | measured at umbilical level | after first dose intervention to next 120 hours |
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