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The study was prematurely terminated because of unavailibility of Methylnaltrexone in the region
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythromycin | Active Comparator | 21 patients admitted in ICU with intolerance to enteral feeding defined as more than 250 ml of gastric residual volume (GRV) found by aspiration technique. |
|
| Methylnaltrexone | Active Comparator | 21 patients admitted in ICU with intolerance to enteral feeding defined as more than 250 ml of gastric residual volume (GRV) found by aspiration technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythromycin | Drug | Erythromycin 250 mg intravenous Q6h for 4 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying time | to measure gastric emptying time within 8 hours after administration of either 4 doses of 250 mg intravenous erythromycin Q6h or 2 doses of methylnaltrexone 12 mg subcutaneous Q12h with acetaminophen absorption test method | within 8 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance to enteral feeding | Tolerance to enteral feeding administered via nasogastric tube within 24 hours after administration of either erithromycin 250 mg intravenous Q6h or methylnaltrexone 12 mg subcutaneous Q12h.Gastric residual volume will be measured Q4h by aspiration method and if less than 250 ml would be considered as tolerance to enteral feeding. | 24 hours after intervention |
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Inclusion Criteria:
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:
Patients on hemodialysis or CRRT
Hemodynamically unstable patients including:
Documented or suspected pregnancy
Obesity; actual body weight more than 1.5 times ideal body weight
Myasthenia Gravis.
Opioid drug abuse
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemazee Hospital | Shiraz | Fars | 71937-11351 | Iran |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D004917 | Erythromycin |
| C032257 | methylnaltrexone |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Methylnaltrexone |
| Drug |
Methylnaltrexone 12 mg subcutaneous Q12h for 2 doses |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |