Clinical trial NCT01050595: Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit
Official title: Methylnaltrexone for the Reversal of Opiate-Induced Constipation in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Opioid-induced Constipation
Keywords: Intensive Care Unit
Constipation
Bowel Management
Lead sponsor: St. John Health System, Michigan
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there will be a significantly higher incidence of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with decreased need for rescue medications in the intensive care unit in patients with opioid-induced constipation. Patients will also be managed with an aggressive bowel management protocol.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older in the ICU
* Opioids for analgesia for at least 24 hours.
* Opioid-induced constipation with no bowel movement within the last 72 hours.
* Women of childbearing potential had negative pregnancy tests.

Exclusion Criteria:

* Contraindication to use of the GI tract
* Diarrhea on admission
* Bowel surgery within 8 weeks of admission
* Ileostomy or colostomy
* Not expected to live or stay more than 3 days in the intensive care unit
* Constipation that was not primarily caused by opioids (as determined by the investigator)
* No opioid use in the last 24 hours,
* Mechanical gastrointestinal obstruction
* An indwelling peritoneal catheter
* Clinically active diverticular disease
* Fecal impaction
* Acute surgical abdomen
* History of Crohn's disease or ulcerative colitis
* On Palliative care
* Less than 18 years old
* Bowel movement in last 72 hours.

Primary outcomes:
measure: A significantly higher incidence of a rescue free laxation with methylnaltrexone within 4 hours +- 45 minutes.
timeFrame: Nine months
Secondary outcomes:
measure: Decreased need for rescue medications to have a bowel movement in the treatment arm vs placebo.
timeFrame: Nine months
Other outcomes:
Locations:
city: Southfield
country: United States
facility: Providence Hospital and Medical Center
state: Michigan
Study officials:
affiliation: Providence Hospital and Medical Center
name: Bradford A Whitmer, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ritchie G, Burgess L, Mostafa S, Wenstone R. Preventing constipation in critically ill patients. Nurs Times. 2008 Nov 18-24;104(46):42-4.
citation: Patanwala AE, Abarca J, Huckleberry Y, Erstad BL. Pharmacologic management of constipation in the critically ill patient. Pharmacotherapy. 2006 Jul;26(7):896-902. doi: 10.1592/phco.26.7.896.
citation: Chappell D, Rehm M, Conzen P. Opioid-induced constipation in intensive care patients: relief in sight? Crit Care. 2008;12(4):161. doi: 10.1186/cc6930. Epub 2008 Jul 1.
citation: Mostafa SM, Bhandari S, Ritchie G, Gratton N, Wenstone R. Constipation and its implications in the critically ill patient. Br J Anaesth. 2003 Dec;91(6):815-9. doi: 10.1093/bja/aeg275.
citation: Tittle M, McMillan SC. Pain and pain-related side effects in an ICU and on a surgical unit: nurses' management. Am J Crit Care. 1994 Jan;3(1):25-30.
citation: Viscusi ER, Gan TJ, Leslie JB, Foss JF, Talon MD, Du W, Owens G. Peripherally acting mu-opioid receptor antagonists and postoperative ileus: mechanisms of action and clinical applicability. Anesth Analg. 2009 Jun;108(6):1811-22. doi: 10.1213/ane.0b013e31819e0d3a.
citation: Arpino PA, Thompson BT. Safety of enteral naloxone for the reversal of opiate-induced constipation in the intensive care unit. J Clin Pharm Ther. 2009 Apr;34(2):171-5. doi: 10.1111/j.1365-2710.2008.00982.x.
citation: McKenna S, Wallis M, Brannelly A, Cawood J. The nursing management of diarrhoea and constipation before and after the implementation of a bowel management protocol. Aust Crit Care. 2001 Feb;14(1):10-6. doi: 10.1016/s1036-7314(01)80017-5.
citation: Dorman BP, Hill C, McGrath M, Mansour A, Dobson D, Pearse T, Singleton J, Al-Omoush A, Barry M, Colongon AR, Perez M, Fitzgerald D, Zabala M. Bowel management in the intensive care unit. Intensive Crit Care Nurs. 2004 Dec;20(6):320-9. doi: 10.1016/j.iccn.2004.09.004.
citation: Hill S, Anderson J, Baker K, Bonson B, Gager M, Lake E. Management of constipation in the critically ill patient. Nurs Crit Care. 1998 May-Jun;3(3):134-7.
citation: Sanz Rubiales A, del Valle Rivero ML. Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med. 2008 Sep 4;359(10):1070-1; author reply 1071. doi: 10.1056/NEJMc081373. No abstract available.