Clinical Trial: Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.

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 Summary:

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

Sponsor: Texas Tech University Health Sciences Center, El Paso

Current Primary Outcome:

  • erythromycin, metoclopromide vs control enabling visualization of the entire gastric mucosa . [ Time Frame: 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 [ Time Frame: 45 minutes ]
    Whether erythromycin, metoclopramide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al


Original Primary Outcome:

  • 1. Wither erythromycin, metoclopromide vs control can enable visualization of the entire gastric mucosa . [ Time Frame: 45 minutes ]
  • 2. Wither erythromycin, metoclopromide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al [ Time Frame: 45 minutes ]


Current Secondary Outcome:

  • Source of bleeding [ Time Frame: 45 minutes ]
    Ability to identify the source of bleeding
  • Second-look endoscopy [ Time Frame: 48 hours ]
    Need for second-look endoscopy
  • Blood units transfused [ Time Frame: 48 hours ]
    Mean number of blood units transfused
  • Mortality [ Time Frame: 30 days ]
    All cause mortality


Original Secondary Outcome:

  • Ability to identify the source of bleeding [ Time Frame: 45 minutes ]
  • Need for second-look endoscopy [ Time Frame: 48 hours ]
  • Mean number of blood units transfused [ Time Frame: 48 hours ]
  • All cause mortality [ Time Frame: 30 days ]


Information By: Texas Tech University Health Sciences Center, El Paso

Dates:
Date Received: December 16, 2013
Date Started: June 2014
Date Completion:
Last Updated: May 15, 2017
Last Verified: May 2017