MedDataX Logo

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

NCT ID: NCT01117376

Last Updated: 2011-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroparesis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Gastroparesis Erythromycin Methylnaltrexone ICU

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Erythromycin

Intervention Type DRUG

Erythromycin 250 mg intravenous Q6h for 4 doses

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.

Group Type ACTIVE_COMPARATOR

Methylnaltrexone

Intervention Type DRUG

Methylnaltrexone 12 mg subcutaneous Q12h for 2 doses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Erythromycin

Erythromycin 250 mg intravenous Q6h for 4 doses

Intervention Type DRUG

Methylnaltrexone

Methylnaltrexone 12 mg subcutaneous Q12h for 2 doses

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shiraz University of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nemazee Hospital

Shiraz, Fars, Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CT-88-01-36-1601

Identifier Type: -

Identifier Source: org_study_id