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

Primary Purpose

Gastroparesis

Status
Terminated
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Erythromycin
Methylnaltrexone
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring Gastroparesis, Erythromycin, Methylnaltrexone, ICU

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nemazee Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Erythromycin

Methylnaltrexone

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 30, 2010
Last Updated
March 30, 2011
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01117376
Brief Title
Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients
Official Title
Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients Intolerant to Enteral Feeding
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely terminated because of unavailibility of Methylnaltrexone in the region
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Gastroparesis, Erythromycin, Methylnaltrexone, ICU

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erythromycin
Arm Type
Active Comparator
Arm 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.
Arm Title
Methylnaltrexone
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Erythromycin
Intervention Description
Erythromycin 250 mg intravenous Q6h for 4 doses
Intervention Type
Drug
Intervention Name(s)
Methylnaltrexone
Intervention Description
Methylnaltrexone 12 mg subcutaneous Q12h for 2 doses
Primary Outcome Measure Information:
Title
Gastric emptying time
Description
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
Time Frame
within 8 hours after drug administration
Secondary Outcome Measure Information:
Title
Tolerance to enteral feeding
Description
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.
Time Frame
24 hours after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Nemazee Hospital
City
Shiraz
State/Province
Fars
ZIP/Postal Code
71937-11351
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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