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

This study has been terminated.
(The study was prematurely terminated because of unavailibility of Methylnaltrexone in the region)
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01117376
First received: April 30, 2010
Last updated: March 30, 2011
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Gastroparesis
Drug: Erythromycin
Drug: Methylnaltrexone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients Intolerant to Enteral Feeding

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Gastric emptying time [ Time Frame: within 8 hours after drug administration ] [ Designated as safety issue: No ]
    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:
  • Tolerance to enteral feeding [ Time Frame: 24 hours after intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 42
Study Start Date: May 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117376

Locations
Iran, Islamic Republic of
Nemazee Hospital
Shiraz, Fars, Iran, Islamic Republic of, 71937-11351
Sponsors and Collaborators
Shiraz University of Medical Sciences
  More Information

No publications provided

Responsible Party: M. H. Dabbaghmanesh, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01117376     History of Changes
Other Study ID Numbers: CT-88-01-36-1601
Study First Received: April 30, 2010
Last Updated: March 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Shiraz University of Medical Sciences:
Gastroparesis
Erythromycin
Methylnaltrexone
ICU

Additional relevant MeSH terms:
Critical Illness
Gastroparesis
Disease Attributes
Pathologic Processes
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Erythromycin stearate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Methylnaltrexone
Naltrexone
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014