Metoclopramide for Gastric Visualization in Active Upper GI Bleeding

Upper GI Bleeding Clinical Trial

Official title:

Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Multicenter, Double-blind Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167837
• Other study ID #: Metoclopramide.UGIB
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: King Chulalongkorn Memorial Hospital
• Contact: Thanrada Vimonsuntirungsri, MD
• Phone: +66853356240
• Email: aa_choc[@]docchula.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aim to evaluate the efficacy of metoclopramide for gastric visualization in patients with active UGIB. This is a double-blinded, multicenter RCT. Patients with 'active' UGIB (hematemesis or presence of fresh blood in the nasogastric tube) were enrolled. The eligible patients were randomly assigned in a concealed 1:1 allocation to received either intravenous metoclopramide or placebo before endoscopy. The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). Secondary outcomes included mean difference in total EVS and EVS at each location , duration of EGD, immediate hemostasis, need for a second look EGD, units of blood transfusion, length of hospital stay and 30-day rebleeding rate.

Description:

- This is double-blinded, multicenter RCT including six hospitals in Thailand. - The participated endoscopists had work experience for endoscopy more than three years. - All endoscopists at six participating sites attended the pre-study meeting for standardization of the protocol and scoring system. - The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). ; To assess overall endoscopic visualization, we estimated the coverage of a blood clot on mucosa in four locations including 1) gastric fundus, 2) corpus, 3) antrum and 4) duodenal bulb, according to the reference endoscopic views in protocal. - All photos, including the reference endoscopic views, were taken and internally validated by another endoscopist who was blinded to the randomization allocation. - This study includes pre-specified subgroup analysis by location of bleeding including gastric subgroup analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 30, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients (aged = 18years)
• Active UGIB who arrived at emergency room (ER) and had a schedule for EGD within 12 hours after onset of bleeding ; Active UGIB was defined as having hematemesis or fresh blood by diagnostic gastric lavage at the ER.

Exclusion Criteria:

• known allergy to metoclopramide
• prior gastric or duodenal surgery
• known case of esophageal, gastric or duodenal cancer;
• advanced HIV infection (defined as WHO criteria13-15: CD4 <200 cell/mm3 or WHO clinical stage 3 or 4)
• pregnancy
• gastric lavage was performed with solution > 50 ml.

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper GI Bleeding

Intervention

Drug:
• Metoclopramide Sulfone
Metoclopramide 10mg+NSS 10 ml IV 30-60 minutes before EGD
• Normal Saline 10 mL Injection
Normal saline 10 ml IV 30-60 minutes before EGD

Locations

Country	Name	City	State
Thailand	King Chulalongkorn memorial hospital	Bangkok
Thailand	King Chulalongkorn Memorial hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with 'adequate visualization'	'adequate visualization' is determined by objective scoring method (endoscopic visualized scores (EVS) to estimate the coverage of a blood clot on mucosa in four locations including 1) gastric fundus, 2) corpus, 3) antrum and 4) duodenal bulb; At each location was assessed and scored between 0 and 2: 0, blood clot cover more than 75% of the surface ; 1, 25-75% blood clot coverage ; 2, blood clot coverage less than 25%. ; score >=6 considered as adequate visualization	Through study completion, estimate 2 years
Secondary	The mean difference in EVS	total of four locations and at each location including fundus, corpus, antrum and duodenal bulb	Through study completion, estimate 2 years
Secondary	Duration of esophagogastroduodenoscopy		10minutes to 2 hours
Secondary	Immediate hemostasis	Rate of succession of hemostasis (bleeding stop) at first EGD	Through study completion, estimate 2 years
Secondary	The need for a second look EGD within 72 hours after initial endoscopy	Rate of need for a second look EGD within 72 hours after initial endoscopy The 72-hour recurrent GI bleeding was documented and re-EGD was performed to confirm rebleeding if the following conditions were met: I) hematemesis or bloody nasogastric tube (NG) > 6 hours after endoscopy; II) melena after normalization of stool color; III) hematochezia after normalization of stool color or melena; IV) development of tachycardia (HR = 110 bpm) or hypotension(SBP = 90 mmHg) after = 1 hour of vital sign stability without other cause; V) hemoglobin drop of = 2 g/dL after two consecutive stable hemoglobin values ( < 0.5 g/dL decrease) = 3 hours apart; VI) tachycardia or hypotension that does not resolve within 8 hours after index endoscopy despite appropriate resuscitation (in the absence of an alternative explanation), associated with persistent melena or hematochezia or; VII) persistently dropping hemoglobin of > 3 g/dL in 24 hours associated with persistent melena or hematochezia.	Up to 72 hours
Secondary	Number of unit of red blood cell transfusion during first 24 hours	Number of of unit of red blood cell transfusions during first 24 hours	Up to 24 hours
Secondary	Length of hospital stays	Length of hospital stays of participants	1day - 30days
Secondary	30-day rebleeding rate	rate of 30-day rebleeding of upper GI tract	Up to 30 days