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This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs (Drugs which are known to speed up the emptying of the stomach or in other words to move the blood out of the stomach faster) given before endoscopy to patients with upper Gastrointestinal bleeding compared to patients who will not receive either of these medications before their endoscopy.
To compare the efficacy of pre-endoscopic interventions namely erythromycin, metoclopromide vs control in improving the outcomes of endoscopy in ICU patients admitted upper GI bleeding.
Specific aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythromycin | Experimental | Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure |
|
| Metoclopromide | Experimental | Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy |
|
| Control | No Intervention | no medications will be given prior to endoscopy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythromycin | Drug |
|
| |
| Metoclopromide |
| Measure | Description | Time Frame |
|---|---|---|
| Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa . | Whether erythromycin, metoclopramide versus control can enable visualization of the entire gastric mucosa . | 45 minutes |
| Erythromycin, Metoclopromide vs Control Improving the Quality of Stomach and Duodenum Visualization | Whether erythromycin, metoclopramide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al | 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Source of Bleeding | Ability to identify the source of bleeding | 45 minutes |
| Second-look Endoscopy | Need for second-look endoscopy | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
Patients younger than 18 yrs old or older than 80 yrs
Patients who refuse to consent to be in our study
Pregnant patients
Prior use of prokinetics in the last 48 hours
History of cardiac arrhythmia
Allergy to erythromycin or metoclopromide
Patients with QT prolongation (query 7)
-
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed O Othman, MD | Texas Tech University Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University Health Science Center | El Paso | Texas | 79905 | United States |
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The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erythromycin | Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Erythromycin |
| FG001 | Metoclopromide | Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Metoclopromide |
| FG002 | Control | no medications will be given prior to endoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erythromycin | Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Erythromycin |
| BG001 | Metoclopromide | Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Metoclopromide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa . | Whether erythromycin, metoclopramide versus control can enable visualization of the entire gastric mucosa . | The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available. | Posted | 45 minutes |
|
The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erythromycin | Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Erythromycin |
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The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Compliance Officer | Texas Tech University Health Sciences Center at El Paso | 915-215-4814 | jackie.roberts@ttuhsc.edu |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D008551 | Melena |
| D006396 | Hematemesis |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D004918 | Erythromycin Estolate |
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Drug |
|
|
| Blood Units Transfused | Mean number of blood units transfused | 48 hours |
| Mortality | All cause mortality | 30 days |
| BG002 | Control | no medications will be given prior to endoscopy |
| BG003 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| OG002 | Control | no medications will be given prior to endoscopy |
|
| Primary | Erythromycin, Metoclopromide vs Control Improving the Quality of Stomach and Duodenum Visualization | Whether erythromycin, metoclopramide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al | The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available. | Posted | 45 minutes |
|
|
| Secondary | Source of Bleeding | Ability to identify the source of bleeding | The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available. | Posted | 45 minutes |
|
|
| Secondary | Second-look Endoscopy | Need for second-look endoscopy | The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available. | Posted | 48 hours |
|
|
| Secondary | Blood Units Transfused | Mean number of blood units transfused | The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available. | Posted | 48 hours |
|
|
| Secondary | Mortality | All cause mortality | The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available. | Posted | 30 days |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Metoclopromide | Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Metoclopromide | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Control | no medications will be given prior to endoscopy | 0 | 0 | 0 | 0 | 0 | 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014839 | Vomiting |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D001549 |
| Benzamides |
| D000577 | Amides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |