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

Phase 2

Terminated

• Conditions: Gastroparesis
• Interventions: Drug: Erythromycin; Drug: Methylnaltrexone

• Registration Number: NCT01117376
• Lead Sponsor: Shiraz University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-30
• Status Verified: 2010-05
• Study Start: 2010-05
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Last Update Submitted: 2011-03-30
• Last Update Posted: 2011-03-31
• Primary Completion: 2011-06
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erythromycin	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.
Methylnaltrexone	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.

Primary Outcome Measures

Name	Time	Method
Gastric emptying time	within 8 hours after drug administration	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

Secondary Outcome Measures

Name	Time	Method
Tolerance to enteral feeding	24 hours after intervention	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.

Trial Locations

Locations (1)

Nemazee Hospital; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of