Critically Ill, Paralytic Ileus
Conditions
Keywords
Prokinetic, Prucalopride
Brief summary
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.
Detailed description
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.
Interventions
DRUGPrucalopride
1-2 mg once daily enteral feeding for 5 consecutive days
DRUGPlacebo
1/2-1 tablet once daily enteral feeding for 5 consecutive days
Sponsors
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The intervention was blinded to patients, nurse, investigators, and radiologist
Intervention model description
Consecutive enrolment parallel group in intervention group and placebo group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of maximum bowel diameter from baseline at 120 hours | after first dose intervention to next 120 hours | measure on plain abdominal radiography by blinded radiologist |
| Change of maximum bowel diameter from baseline at 24 hours | after first dose intervention to next 24 hours | measure on plain abdominal radiography by blinded radiologist |
| Change of maximum bowel diameter from baseline at 48 hours | after first dose intervention to next 48 hours | measure on plain abdominal radiography by blinded radiologist |
| Change of maximum bowel diameter from baseline at 72 hours | after first dose intervention to next 72 hours | measure on plain abdominal radiography by blinded radiologist |
| Change of maximum bowel diameter from baseline at 96 hours | after first dose intervention to next 96 hours | measure on plain abdominal radiography by blinded radiologist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of abdominal circumference from baseline at 24 hours | after first dose intervention to next 24 hours | measured at umbilical level |
| change of abdominal circumference from baseline at 48 hours | after first dose intervention to next 48 hours | measured at umbilical level |
| change of abdominal circumference from baseline at 72 hours | after first dose intervention to next 72 hours | measured at umbilical level |
| change of abdominal circumference from baseline at 96 hours | after first dose intervention to next 96 hours | measured at umbilical level |
| change of abdominal circumference from baseline at 120 hours | after first dose intervention to next 120 hours | measured at umbilical level |
Countries
Thailand
Contacts
Primary ContactPanu Wetwittayakhlang, Dr.
Outcome results
None listed