Alvimopan Use in Polytraumatized Patients

Phase 4TerminatedNCT03068975

University of Puerto Rico3 enrolled

Overview

To evaluate the efficacy and safety of Alvimopan(12 mg) in recovery of bowel function in an emergency trauma setting without the pre-operative dosage in patients that will receive abdominal surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Post Operative Ileus

Interventions

AlvimopanDRUG

Patients who sustained abdominal trauma with resection of bowel and anastomosis will receive Alvimopan ( post operative dose only) and will monitor for post operative ileus.

PlaceboDRUG

Patients who sustained abdominal trauma with resection of bowel and anastomosis will receive the Placebo Pill (post operative dose only) and will monitor for post operative ileus.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ages 18 to 80 * Poly-traumatized patients * Extubated patients after abdominal exploration * Underwent Abdominal exploration, had colon resection with primary anastomosis with closure of abdomen Exclusion Criteria: * Mechanically ventilated patients * Patient not expected to survive Glasgow Coma Scale = 3 * Pregnant patients * Apache score \> 40 (observed mortality 100%) Saas Ahmed Naved et al 2011 * Vasopressor therapy * Septic patients * Thoracotomy * Bogota bag * Intravenous Drug Abuser (IVDA) as evidenced by urine toxicology upon admission to the Trauma Unit * Patients with prior history of gastric surgery and/or colonic surgery * Medical History: of severe cardiovascular disease, Renal diseases, Hepatitis C or Hepatic failure, Autoimmune disease, Crohn and Ulcerative Colitis (In view of the inflammation in the intestinal mucosal which may decrease optimal absorption of the medication) and or bowel obstruction * Prior pancreatic anastomosis or gastric anastomosis; ostomy formation * Chronic use of nonsteroidal anti-inflammatory drugs

Locations (1)

Puerto Rico Trauma Hospital

San Juan, US, Puerto Rico

Outcomes

Primary Outcomes

Recovery of bowel function in trauma patients who received post operative dose of Alvimopan compared to placebo.

Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus hence the bowel recovery will be faster. By physical examination (passage of flatus, bowel movements upon auscultation) will be used to assess recovery of bowel function

Time frame: 2 years

Secondary Outcomes

Length of stay in patients of the same population who receive a placebo.

Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus and all the associated complications that prolonged the length of stay of the patients, hence it will reduce the hospital days of the individual

Time frame: 5 years

Data from ClinicalTrials.gov

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