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

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01117376
• Other study ID #: CT-88-01-36-1601
• Status: Terminated
• Phase: Phase 2
• First received: April 30, 2010
• Last updated: March 30, 2011
• Start date: May 2010
• Est. completion date: August 2011

Study information

• Verified date: May 2010
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Gastroparesis

Intervention

Drug:
• Erythromycin
Erythromycin 250 mg intravenous Q6h for 4 doses
• Methylnaltrexone
Methylnaltrexone 12 mg subcutaneous Q12h for 2 doses

Locations

Country	Name	City	State
Iran, Islamic Republic of	Nemazee Hospital	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No