Alvimopan Use in Polytraumatized Patients

Post Operative Ileus Clinical Trial

Official title:

A Double Blind, Randomized, Parallel Design Study to Evaluate the Effectiveness of Post-operative Dose of Alvimopan(Entereg) in Preventing Post-operative Ileus in Poly-traumatized Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03068975
• Other study ID #: 55238
• Status: Terminated
• Phase: Phase 4
• Start date: September 1, 2017
• Est. completion date: November 19, 2019

Study information

• Verified date: January 2020
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 19, 2019
• Est. primary completion date: November 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ileus
• Post Operative Ileus

Intervention

Drug:
• Alvimopan
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.
• Placebo
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.

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico Trauma Hospital	San Juan

Sponsors (2)

Lead Sponsor	Collaborator
University of Puerto Rico	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Puerto Rico, 

References & Publications (18)

Bragg D, El-Sharkawy AM, Psaltis E, Maxwell-Armstrong CA, Lobo DN. Postoperative ileus: Recent developments in pathophysiology and management. Clin Nutr. 2015 Jun;34(3):367-76. doi: 10.1016/j.clnu.2015.01.016. Epub 2015 Jan 31. Review. — View Citation

Delaney CP, Senagore AJ, Viscusi ER, Wolff BG, Fort J, Du W, Techner L, Wallin B. Postoperative upper and lower gastrointestinal recovery and gastrointestinal morbidity in patients undergoing bowel resection: pooled analysis of placebo data from 3 randomized controlled trials. Am J Surg. 2006 Mar;191(3):315-9. — View Citation

Delaney CP, Weese JL, Hyman NH, Bauer J, Techner L, Gabriel K, Du W, Schmidt WK, Wallin BA; Alvimopan Postoperative Ileus Study Group. Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major abdominal surgery. Dis Colon Rectum. 2005 Jun;48(6):1114-25; discussion 1125-6; author reply 1127-9. — View Citation

Earnshaw SR, Kauf TL, McDade C, Potashman MH, Pauyo C, Reese ES, Senagore A. Economic Impact of Alvimopan Considering Varying Definitions of Postoperative Ileus. J Am Coll Surg. 2015 Nov;221(5):941-50. doi: 10.1016/j.jamcollsurg.2015.08.004. Epub 2015 Aug 15. — View Citation

Herzog TJ, Coleman RL, Guerrieri JP Jr, Gabriel K, Du W, Techner L, Fort JG, Wallin B. A double-blind, randomized, placebo-controlled phase III study of the safety of alvimopan in patients who undergo simple total abdominal hysterectomy. Am J Obstet Gynecol. 2006 Aug;195(2):445-53. Epub 2006 Apr 19. — View Citation

Hilton WM, Lotan Y, Parekh DJ, Basler JW, Svatek RS. Alvimopan for prevention of postoperative paralytic ileus in radical cystectomy patients: a cost-effectiveness analysis. BJU Int. 2013 Jun;111(7):1054-60. doi: 10.1111/j.1464-410X.2012.11499.x. Epub 2012 Nov 21. — View Citation

Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. Review. — View Citation

Kalff JC, Schraut WH, Simmons RL, Bauer AJ. Surgical manipulation of the gut elicits an intestinal muscularis inflammatory response resulting in postsurgical ileus. Ann Surg. 1998 Nov;228(5):652-63. — View Citation

Ludwig K, Enker WE, Delaney CP, Wolff BG, Du W, Fort JG, Cherubini M, Cucinotta J, Techner L. Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway. Arch Surg. 2008 Nov;143(11):1098-105. doi: 10.1001/archsurg.143.11.1098. — View Citation

Ludwig K, Viscusi ER, Wolff BG, Delaney CP, Senagore A, Techner L. Alvimopan for the management of postoperative ileus after bowel resection: characterization of clinical benefit by pooled responder analysis. World J Surg. 2010 Sep;34(9):2185-90. doi: 10.1007/s00268-010-0635-9. — View Citation

Manger JP, Nelson M, Blanchard S, Helo S, Conaway M, Krupski TL. Alvimopan: A cost-effective tool to decrease cystectomy length of stay. Cent European J Urol. 2014;67(4):335-41. doi: 10.5173/ceju.2014.04.art4. Epub 2014 Dec 5. — View Citation

Miedema BW, Johnson JO. Methods for decreasing postoperative gut dysmotility. Lancet Oncol. 2003 Jun;4(6):365-72. Review. — View Citation

Naved SA, Siddiqui S, Khan FH. APACHE-II score correlation with mortality and length of stay in an intensive care unit. J Coll Physicians Surg Pak. 2011 Jan;21(1):4-8. doi: 01.2011/JCPSP.0408. — View Citation

Simorov A, Thompson J, Oleynikov D. Alvimopan reduces length of stay and costs in patients undergoing segmental colonic resections: results from multicenter national administrative database. Am J Surg. 2014 Dec;208(6):919-25; discussion 925. doi: 10.1016/j.amjsurg.2014.08.011. Epub 2014 Sep 22. — View Citation

Thompson M, Magnuson B. Management of postoperative ileus. Orthopedics. 2012 Mar;35(3):213-7. doi: 10.3928/01477447-20120222-08. — View Citation

Vaughan-Shaw PG, Fecher IC, Harris S, Knight JS. A meta-analysis of the effectiveness of the opioid receptor antagonist alvimopan in reducing hospital length of stay and time to GI recovery in patients enrolled in a standardized accelerated recovery program after abdominal surgery. Dis Colon Rectum. 2012 May;55(5):611-20. doi: 10.1097/DCR.0b013e318249fc78. Review. — View Citation

Winegar B, Cox M, Truelove D, Brock G, Scherrer N, Pass LA. Efficacy of alvimopan following bowel resection: a comparison of two dosing strategies. Ann Pharmacother. 2013 Nov;47(11):1406-13. doi: 10.1177/1060028013504289. — View Citation

Wolff BG, Michelassi F, Gerkin TM, Techner L, Gabriel K, Du W, Wallin BA; Alvimopan Postoperative Ileus Study Group. Alvimopan, a novel, peripherally acting mu opioid antagonist: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus. Ann Surg. 2004 Oct;240(4):728-34; discussion 734-5. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Secondary	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	5 years