Alvimopan Use in Polytraumatized Patients

University of Puerto Rico (UPR)

Status and phase

Terminated

Phase 4

Conditions

Post Operative Ileus

Treatments

Drug: Placebo

Drug: Alvimopan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03068975

55238

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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