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

NCT01117376 | Terminated Phase 2

• 1 other identifier: CT-88-01-36-1601
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Keywords

Gastroparesis; Erythromycin; Methylnaltrexone; ICU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tolerance to enteral feeding

  24 hours after intervention

Study Arms (2)

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.

Drug: Erythromycin

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.

Drug: Methylnaltrexone

Interventions

Erythromycin DRUG

Erythromycin 250 mg intravenous Q6h for 4 doses

Erythromycin

Methylnaltrexone DRUG

Methylnaltrexone 12 mg subcutaneous Q12h for 2 doses

Methylnaltrexone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known allergy to interventional drugs or acetaminophen
• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Nemazee Hospital

Shiraz, Fars, 71937-11351, Iran

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Erythromycin; methylnaltrexone

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 5, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 31, 2011

Record last verified: 2010-05

Locations

IR (1)