Metoclopramide, Azithromycin, or Nondrug Pretreatment for UGIB to Reduce Second Endoscopy
Status:
Recruiting
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
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 is highly dependent on adequate visualization of the entire gastric
mucosa. Metoclopramide has previously been investigated as a prokinetic agent to aid gastric
emptying prior to endoscopy, but its widespread adoption is limited by a lack of high quality
clinical evidence as well as concerns regarding side effects. Erythromycin is currently the
only prokinetic agent recommended by the American and the European guidelines for use in
selected patients in order to reduce the need for second endoscopy. Its clinical application,
however, is limited by risk of arrhythmia, significant drug interactions, and frequent drug
shortages. Azithromycin is structurally related to erythromycin, but is devoid of most
adverse side effects associated with erythromycin use. Early evidence suggests that
azithromycin may be an effective alternative to erythromycin in the treatment of
gastroparesis. The current study, an interventional, randomized, triple-blinded,
placebo-controlled clinical trial, is primarily aimed to evaluate the effectiveness of
azithromycin as a prokinetic agent in the management of UGIB. It is also aimed to further
evaluate the role of metoclopramide as a prokinetic agent in this setting. Outcome measures
to be collected in this study include the need for secondary endoscopy, overall mortality,
transfusion requirement, length of stay, requirement for surgery, and incidence of adverse
side effects. Results from this study would help identify a safe, effective, and readily
available prokinetic agent to be used prior to endoscopy.