Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to test if metoclopramide can improve effectiveness of endoscopic intervention in upper gastrointestinal (GI) bleeds. The main questions the investigators hope to answer is
Does metoclopramide lessen the need for repeat endoscopy, interventional radiology intervention or surgery in cases of upper GI bleed?
Does metoclopramide improve visibility of the GI walls in cases of upper GI bleed?
The purpose of the study is to see if giving metoclopramide prior to an endoscopy in cases of upper GI bleed can decrease the need for repeat endoscopy due to poor visibility. Metoclopramide stimulates stomach and intestine activity. It is used to treat nausea, vomiting and slow gut movement. The investigators are testing if metoclopramide's effect on stimulating stomach activity can lead to more effective emptying of blood from the stomach and upper intestines in upper GI bleeding so physicians conducting endoscopies can easily see the stomach and intestinal wall and treat the source of bleeding.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoclopramide | Experimental | Given 10 mg Metoclopramide prior to Endoscopy |
|
| Placebo | Placebo Comparator | Given saline flush prior to Endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide 10mg | Drug | IV Metoclopramide |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility | Will collect if repeat procedure occurred due to poor visibility (True/False) | During Current Hospitalization (up to day 14) |
| Toronto Upper Gastroenterology Cleaning Score (TUGS) | Standardized 0-12 point scale for describing upper gastrointestinal tract visibility, 0 indicating poor visibility, and 12 indicating excellent visibility | During Endoscopy Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital stay (days) | Time in days between admission and discharge | During Current Hospitalization (up to day 14) |
| Types of Adverse Neurological Side effects | Dystonia, Akathisia, Parkinsonism, Tardive Dyskinesia, Other |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mudassar K Sandozi, DO | Contact | (815) 971-2544 | msandozi@mhemail.org | |
| Altaf Dawood, MD | Contact | (815) 971-2544 | adawood@mhemail.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Javon Bea Hospital-Riverside - MercyHealth | Recruiting | Rockford | Illinois | 61114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20970794 | Background | Barkun AN, Bardou M, Martel M, Gralnek IM, Sung JJ. Prokinetics in acute upper GI bleeding: a meta-analysis. Gastrointest Endosc. 2010 Dec;72(6):1138-45. doi: 10.1016/j.gie.2010.08.011. | |
| 35642290 | Background | Khan R, Gimpaya N, Vargas JI, Ramkissoon A, Seleq S, Gholami R, Akhtar HJ, Bansal R, Scaffidi MA, Amin S, Bollipo S, Kral J, Lui R, Pawlak KM, Sandhu DS, Bilal M, de-Madaria E, Siau K, Charabaty A, Hashim A, Sanchez-Luna SA, Teshima CW, May GR, Mosko JD, Walsh CM, Grover SC. The Toronto Upper Gastrointestinal Cleaning Score: a prospective validation study. Endoscopy. 2023 Feb;55(2):121-128. doi: 10.1055/a-1865-4180. Epub 2022 May 31. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D006470 | Hemorrhage |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
Not provided
Not provided
Not provided
Not provided
Not provided
Randomization protocol instituted by pharmacy, patient and endoscopist blinded to treatment assignment.
| Saline | Drug | Placebo |
|
| 3 month f/u |
| Glasgow-Blatchford Bleeding Score | Score from 0-29 estimating risk of gastrointestinal bleed and need for inpatient admission, 0 indicating low risk, 29 indicating high risk of mortality | within 3 hours after admission |
| Endoscopy Findings | Findings of endoscopy | During Endoscopy Procedure |
| Endoscopy Start and End Times | Start and stop times of endoscopies | During Endoscopy Procedure |
| Number of Blood Units Transfused in 24 hours | measure in units of blood transfused | within 24 hours after admission |
| 21704823 | Background | Daram SR, Garretson R. Erythromycin is preferable to metoclopramide as a prokinetic in acute upper GI bleeding. Gastrointest Endosc. 2011 Jul;74(1):234; author reply 234-5. doi: 10.1016/j.gie.2011.01.059. No abstract available. |
| 33929377 | Background | Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. Am J Gastroenterol. 2021 May 1;116(5):899-917. doi: 10.14309/ajg.0000000000001245. |
| Background | Metoclopramide for Acute Upper GI Bleeding - Tabular View - ClinicalTrials.Gov. https://clinicaltrials.gov/ct2/show/record/NCT04771481. Accessed 7 Feb. 2023. |
| 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 |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |