The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit (NCT02705378) | Clinical Trial Compass
WithdrawnPhase 3
The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit
Stopped: PI left institution. Protocol never submitted to the IRB, no contract executed only Confidentiality Agreement, and study not done.
United States0Started 2017-05
Plain-language summary
Naloxegol has recently been approved by the US Food and Drug Administration to treat opioid induced constipation in non-cancer chronic pain patients. Its effectiveness in acute care patients, however, is not known. Therefore, the researchers' goal is to investigate whether naloxegol is superior to osmotic laxatives for refractory constipation in ICU patients already receiving prophylactic stool softeners and simulant laxatives through a double-blind, randomized control trial.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Age ā„18 years
ā. Admitted to an ICU at Massachusetts General Hospital (MGH)
ā. Received ā„72 hours of continuous opioid infusion
ā. Anticipated to require ā„48 hours of additional care in the ICU
ā. Did not have a bowel movement in ā„72 hours
ā. Allowed to receive (and tolerating) medications via nasogastric, orogastric, gastric, gastrojejunal, or oral route
ā. Receiving at least trophic (10 mL/hr) of enteral nutrition
Exclusion criteria
ā. Unable to provide informed consent or unavailable healthcare proxy
ā. Not expected to survive \>48 hours from time of enrollment
ā. "Comfort measures only" status (i.e. palliative care)
ā
What they're measuring
1
Laxation within 48 hours of starting second-line agent
Timeframe: From 72 hours after ICU admission until 120 hours after ICU admission