Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients
Information source: Shiraz University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroparesis
Intervention: Erythromycin (Drug); Methylnaltrexone (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Shiraz University of Medical Sciences
Summary
42 patients admitted in ICU with intolerance to enteral feeding (GRV more than 250 ml) are
recruited. All patients enter a primary acetaminophen absorption test study as baseline.
Serum levels of acetaminophen will be measured by florescence polarization method at
15,30,45,60,90,120,180,240,480 minutes after enteral administration of 975 mg acetaminophen.
Then the patients will be randomized to methylnaltrexone or erythromycin group. Another
acetaminophen absorption test with the same schedule will be done after the last dose of
each drug. The area under the curve for acetaminophen blood level will be used to compare the
effect of two studied drugs on gastric emptying time.
Clinical Details
Official title: Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients Intolerant to Enteral Feeding
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Gastric emptying time
Secondary outcome: Tolerance to enteral feeding
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients admitted in intensive care unit in a university affiliated hospital
- Receiving continuous enteral feeding through a nasogastric tube
- Gastric residual volume more than 250 ml checked by aspiration technique
Exclusion Criteria:
- Receiving the study drugs or metoclopramide within 24 hours of inclusion
- Known allergy to interventional drugs or acetaminophen
- Gastrointestinal bleeding or surgery on GI system within 24 hours of inclusion
- Crohn's disease
- GI perforation or obstruction
- Short bowel syndrome
- Liver failure or 2 of the followings:
- Transaminase enzymes more than 3 times normal
- Prothrombin time more than 2 times normal
- Total bilirubin more than 3 times normal
- Patients on hemodialysis or CRRT
- Hemodynamically unstable patients including:
- Mean arterial pressure less than 65 mmHg
- Infusion of inotropes and vasopressors
- Uncorrected acute blood loss; hemoglobin concentration less than 6. 5 mg%.
- Documented or suspected pregnancy
- Obesity; actual body weight more than 1. 5 times ideal body weight
- Myasthenia Gravis.
- Opioid drug abuse
Locations and Contacts
Nemazee Hospital, Shiraz, Fars 71937-11351, Iran, Islamic Republic of
Additional Information
Starting date: May 2010
Last updated: March 30, 2011
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