Paralytic ileus
Conditions
Interventions
This is a randomized controlled clinical trial with two parallel arms and single-blind outcome assessor masking including 30 critically ill adult patients in the postoperative period following major a
Sponsors
Hospital Universitario de Caldas
Hospital Departamental Universitario Santa Sofía de Caldas
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients aged 18 years or older; patients undergoing major abdominal surgery; admission to the intensive care unit in the immediate postoperative period; diagnosis of acute intestinal failure type I; catabolic response to surgical trauma; medical indication for initiation of early enteral nutrition within the first 24 hours after surgery; hemodynamic stability without requirement for high-dose vasopressors; written informed consent signed by the patient or legal representative
Exclusion criteria
Exclusion criteria: Age under 18 years; chronic intestinal failure or short bowel syndrome; uncontrolled sepsis or septic shock at the time of inclusion; hemodynamic instability defined by norepinephrine requirement greater than 0.1 micrograms per kilogram per minute or vasopressin greater than 1 unit per hour; previously diagnosed inflammatory bowel disease; mechanical intestinal obstruction; intestinal ischemia; active gastrointestinal bleeding; prolonged use of systemic antibiotics for more than 14 days prior to inclusion; clinical or technical contraindication to postpyloric tube placement; pregnancy; concurrent participation in another interventional clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional intestinal recovery assessed by time to resolution of paralytic ileus and return of bowel transit, measured by the presence of bowel sounds, passage of flatus or stool, reduction of abdominal distension and adequate digestive tolerance to enteral nutrition, associated with a reduction in the number of days of parenteral nutritional support during the first 72 hours after initiation of lipid rich postpyloric enteral nutrition compared to the control group | — |
Secondary
| Measure | Time frame |
|---|---|
| Systemic inflammatory response modulation assessed by changes in serum interleukin six, tumor necrosis factor alpha and C reactive protein between baseline and 72 hours after initiation of the intervention. Intestinal barrier integrity assessed by serum zonulin concentration as an indirect marker of intestinal permeability and absorption. Changes in intestinal microbiota diversity and composition assessed by sixteen S ribosomal gene sequencing and correlated with zonulin levels and clinical recovery parameters. Incidence of infectious complications during intensive care unit stay. Digestive tolerance assessed by the occurrence of vomiting, abdominal distension, diarrhea or need for enteral nutrition interruption | — |
Countries
Colombia
Contacts
Public ContactKevin Montoya
Hospital Universitario de Caldas
Outcome results
None listed