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

S

Shiraz University of Medical Sciences

Status and phase

Terminated
Phase 2

Conditions

Gastroparesis

Treatments

Drug: Methylnaltrexone
Drug: Erythromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT01117376
CT-88-01-36-1601

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 2 patient groups

Erythromycin
Active Comparator group
Description:
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.
Treatment:
Drug: Erythromycin
Methylnaltrexone
Active Comparator group
Description:
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.
Treatment:
Drug: Methylnaltrexone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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