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

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

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.

Study Overview

• Status: Terminated
• Conditions: Gastroparesis
• Intervention / Treatment: Drug: Erythromycin; Drug: Methylnaltrexone

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of, 71937-11351
      • Nemazee Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erythromycin; 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; Erythromycin 250 mg intravenous Q6h for 4 doses
Active Comparator: Methylnaltrexone; 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; Methylnaltrexone 12 mg subcutaneous Q12h for 2 doses

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): August 1, 2011

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (Estimate): May 5, 2010

Study Record Updates

• Last Update Posted (Estimate): March 31, 2011
• Last Update Submitted That Met QC Criteria: March 30, 2011
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Erythromycin; ICU; Gastroparesis; Methylnaltrexone
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Narcotic Antagonists; Protein Synthesis Inhibitors; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Methylnaltrexone
• Other Study ID Numbers: CT-88-01-36-1601