Alvimopan Use in Polytraumatized Patients

• Status: Terminated
• Trial end date: 2019-11-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Puerto Rico
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Alvimopan

Criteria

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