Upper Gastrointestinal Bleeding
Conditions
Keywords
upper gastrointestinal bleeding, melena, hematemesis
Brief summary
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.
Detailed description
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: 1. Wither erythromycin, metoclopromide vs control can enable visualization of the entire gastric mucosa . 2. Wither erythromycin, metoclopromide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al
Interventions
DRUGErythromycin
DRUGMetoclopromide
Sponsors
Texas Tech University Health Sciences Center, El Paso
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients (18-80) * who are admitted to the ICU for hematemesis, or coffee ground emesis
Exclusion criteria
1. Patients younger than 18 yrs old or older than 80 yrs 2. Patients who refuse to consent to be in our study 3. Pregnant patients 4. Prior use of prokinetics in the last 48 hours 5. History of cardiac arrhythmia 6. Allergy to erythromycin or metoclopromide 7. Patients with QT prolongation (query 7) \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa . | 45 minutes | Whether erythromycin, metoclopramide versus control can enable visualization of the entire gastric mucosa . |
| Erythromycin, Metoclopromide vs Control Improving the Quality of Stomach and Duodenum Visualization | 45 minutes | Whether erythromycin, metoclopramide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Source of Bleeding | 45 minutes | Ability to identify the source of bleeding |
| Second-look Endoscopy | 48 hours | Need for second-look endoscopy |
| Blood Units Transfused | 48 hours | Mean number of blood units transfused |
| Mortality | 30 days | All cause mortality |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Erythromycin Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure
Erythromycin | 0 |
| Metoclopromide Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy
Metoclopromide | 0 |
| Control no medications will be given prior to endoscopy | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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 .
Time frame: 45 minutes
Population: 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.
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
Time frame: 45 minutes
Population: 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.
Secondary
Blood Units Transfused
Mean number of blood units transfused
Time frame: 48 hours
Population: 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.
Secondary
Mortality
All cause mortality
Time frame: 30 days
Population: 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.
Secondary
Second-look Endoscopy
Need for second-look endoscopy
Time frame: 48 hours
Population: 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.
Secondary
Source of Bleeding
Ability to identify the source of bleeding
Time frame: 45 minutes
Population: 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.