Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients

Study Overview
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Brief Summary
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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.

Official Title
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Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients Intolerant to Enteral Feeding

Conditions
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Gastroparesis

Intervention / Treatment
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* Drug: Erythromycin
* Drug: Methylnaltrexone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erythromycin<br>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. | Drug: Erythromycin<br>* Erythromycin 250 mg intravenous Q6h for 4 doses<br>|
| Active Comparator: Methylnaltrexone<br>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. | Drug: Methylnaltrexone<br>* Methylnaltrexone 12 mg subcutaneous Q12h for 2 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroparesis, Erythromycin, Methylnaltrexone, ICU