Status:
UNKNOWN
Metoclopramide, Azithromycin, or Nondrug Pretreatment for UGIB to Reduce Second Endoscopy
Lead Sponsor:
Waihong Chung
Conditions:
Gastro Intestinal Bleeding
Upper Gastrointestinal Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Early endoscopy is an integral part of the management plan for patients presenting with clinical signs of severe or ongoing UGIB. An accurate endoscopic diagnosis and successful endoscopic hemostasis ...
Eligibility Criteria
Inclusion
- 1\. Adult patients ≥ 18 years of age at the time of presentation;
- 2\. Admitted to Rhode Island Hospital (RIH) emergency room or inpatient services;
- 3\. Presented with hematemesis, coffee ground emesis, or melena;
- 4\. Upper endoscopy is planned within 24 hours of presentation or onset of bleeding.
Exclusion
- 1\. Known anaphylactic allergic reaction to erythromycin, azithromycin, and/or metoclopramide;
- 2\. Concurrent use of certain medications associated with tardive dyskinesia (TD):
- a. Fluphenazine,
- b. Haloperidol,
- c. Loxapine,
- d. Paliperidone,
- e. Perphenazine,
- f. Pimozide,
- g. Risperidone,
- h. Thiothixene,
- i. Trifluoperazine;
- 3\. Concurrent use of certain medications associated with torsade de pointes:
- a. Amiodarone,
- b. Chlorpromazine,
- c. Disopyramide,
- d. Dofetilide,
- e. Methadone,
- f. Procainamide,
- g. Quinidine,
- h. Sotalol;
- 4\. Known history of TD, ventricular arrhythmias , or long QT syndrome;
- 5\. Already received erythromycin and/or azithromycin within the past 10 days, or metoclopramide within the past 4 days for other indications;
- 6\. Recipient of hematopoietic stem cell transplant;
- 7\. History of Neisseria gonorrhoeae infection;
- 8\. Pregnancy;
- 9\. Prior gastrectomy.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT03840057
Start Date
July 1 2020
End Date
July 1 2021
Last Update
August 7 2020
Active Locations (1)
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1
Rhode Island Hospital
Providence, Rhode Island, United States, 02906