Metoclopramide for Acute Upper GI Bleeding

NCT04771481 | Completed Phase 4 DMC

• 1 other identifier: RP021
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief Summary

The presence of blood clot in stomach limited quality of endoscopic view ,which affect successful rate of hemostatic endoscopy in patient with acute upper gastrointestinal bleeding. The study is aimed to evaluate the efficacy of metoclopramide, as pro-kinetic agent ,for gastric visualization in the patient with acute UGIB; double-blind randomized controlled trial and two centers study. The patient were randomly assigned to receive either metoclopramide (10mg) intravenously or placebo before endoscopy 30-120 min. The primary endpoint was endoscopic yield, assessed by objective gastric visualized scoring systems. Secondary end points include duration of endoscope, technical success rate, the need for second-look EGD, units of blood transfusion, length of hospital stay and 30-day rebleeding rate.

Conditions

Acute Upper Gastrointestinal Bleeding; Effect of Drug

Keywords

Metoclopramide; Acute upper gastrointestinal bleeding; Gastric visualization; Endoscopy

Outcome Measures

Primary Outcomes (1)

• percentage of patents with 'adequate visualization'

  the efficacy of metoclopramide for gastric visualization by endoscopy in patients with acute upper gastrointestinal bleeding which assess by objective gastric visualized scoring system (score 0-8) ; total score \>= 6 consider it as adequate visualization at index EGD

  Though study completion , average 2 yr

Secondary Outcomes (7)

• mean difference in endoscopic visualized gastric score

  Though study completion , average 2 yr

• duration of endoscopy

  up to 2 hour

• immediate hemostasis at index EGD

  Though study completion , average 2 yr

• the need of second-look EGD

  72 hours

• units of red cell transfusion

  up to 30 days

Study Arms (2)

metoclopramide

EXPERIMENTAL

Metoclopramide 10mg with normal saline up to 10 ml IV slowly push in 5minutes.

Drug: Metoclopramide

placebo

PLACEBO COMPARATOR

Normal saline 10 ml IV slowly push in 5 minutes.

Drug: Normal Saline 10 mL Injection

Interventions

Metoclopramide DRUG

Metoclopramide 10 mg + NSS 10 ml intravenous slowly push in 5min before endoscopy 30-120 min

metoclopramide

Normal Saline 10 mL Injection DRUG

Normal saline 10 ml intravenous slowly push in 5min before endoscopy 30-120 min

placebo

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years
• Active upper GI bleeding ( defined as fresh or bright red hematemesis within 24hr. or presented of blood via NG aspiration )
• Underwent upper GI endoscopy within 12hr
• Informed consent obtained

You may not qualify if:

• Known allergy of metoclopramide
• History of gastric or duodenal surgery
• Known case esophageal, gastric or duodenal cancer
• Diagnosed with advanced HIV infection (defined as CD4 cell count \<200 cells/mm3 or WHO clinical stage 3 or 4)
• Pregnancy or lactating
• NG lavage was done with solution \> 50 ml.

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (2)

King chulalongkorn memorial hospital

Bangkok, Pathum Wan, 10400, Thailand

Location

Division of Gastroenterology, Faculty of Medicine, Chulalongkorn University

Bangkok, Pathumwan, 10330, Thailand

Location

Related Publications (1)

• Vimonsuntirungsri T, Thungsuk R, Nopjaroonsri P, Faknak N, Pittayanon R. The Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Double-Blind Randomized Controlled Trial. Am J Gastroenterol. 2024 May 1;119(5):846-855. doi: 10.14309/ajg.0000000000002620. Epub 2023 Dec 7.

  PMID: 38059896 DERIVED

MeSH Terms

Interventions

Metoclopramide; Saline Solution; Injections

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participating endoscopists and patients were blinded to the randomization allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc (Medicine and Experimental Surgery) Associate Professor, Division of Gastroenterology, Faculty of Medicine, Chulalongkorn University Secretary General, the Gastroenterological Association of Thailand (GAT)

Model Details: * Double-blind, Double centers, RCT * The standardized set of endoscopic landmarks, including the esophagus, gastro-esophageal junction, fundus, gastric body, incisura, antrum, duodenal bulb, and second part of the duodenum were examined. * The simple validate objective scoring system was applied; estimated coverage of blood clot on mucosa on reference endoscopies view in 4 locations, including fundus, corpus, antrum and duodenal bulb. * Each location was scored between 0 and 2 Score 0 (worst vision), less than 25% of the surface was visible Score 1 25-75% visible surface Score 2 (best vision), more than 75% visible surface ( total score range 0-8) * 'Adequate visualization' = total score six or higher. * All photos was internally validated by another endoscopist who was blinded to the randomization allocation.

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 25, 2021
• Study Start: April 10, 2021
• Primary Completion: September 7, 2022
• Study Completion: October 8, 2022
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)