Metoclopramide for Gastric Visualization in Active Upper GI Bleeding

NCT06167837 | Unknown Phase 4 DMC

• 1 other identifier: Metoclopramide.UGIB
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Upper GI Bleeding

Keywords

active upper GI bleeding; EGD; Gastric visualization; Metoclopramide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The mean difference in EVS

  Through study completion, estimate 2 years

• Duration of esophagogastroduodenoscopy

  10minutes to 2 hours

• Immediate hemostasis

  Through study completion, estimate 2 years

• The need for a second look EGD within 72 hours after initial endoscopy

  Up to 72 hours

• Number of unit of red blood cell transfusion during first 24 hours

  Up to 24 hours

Study Arms (2)

Metoclopramide group

EXPERIMENTAL

Metoclopramide 10 mg +NSS 10ml IV 30-60 min before EGD

Drug: Metoclopramide Sulfone

Placebo group

PLACEBO COMPARATOR

NSS 10 ml IV 30-60 min before EGD

Drug: Normal Saline 10 mL Injection

Interventions

Metoclopramide Sulfone DRUG

Metoclopramide 10mg+NSS 10 ml IV 30-60 minutes before EGD

Metoclopramide group

Normal Saline 10 mL Injection DRUG

Normal saline 10 ml IV 30-60 minutes before EGD

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (2)

King Chulalongkorn memorial hospital

Bangkok, 10330, Thailand

RECRUITING

King Chulalongkorn Memorial hospital

Bangkok, 10330, Thailand

NOT YET RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

metoclopramide sulfone; Saline Solution; Injections

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Thanrada Vimonsuntirungsri, MD

CONTACT

+66853356240; aa_choc@docchula.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: December 13, 2023
• Study Start: October 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 30, 2025
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)