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Metoclopramide for Acute Upper GI Bleeding

Primary Purpose

Acute Upper Gastrointestinal Bleeding, Effect of Drug

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Metoclopramide
Normal Saline 10 mL Injection
Sponsored by
King Chulalongkorn Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Upper Gastrointestinal Bleeding focused on measuring Metoclopramide, Acute upper gastrointestinal bleeding, Gastric visualization, Endoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • King chulalongkorn memorial hospital
  • Division of Gastroenterology, Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

metoclopramide

placebo

Arm Description

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

Normal saline 10 ml IV slowly push in 5 minutes.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

mean difference in endoscopic visualized gastric score
score 0-2, including total mean score , and at each location of fundus , corpus , antrum and duodenal bulb
duration of endoscopy
duration of endoscopy
immediate hemostasis at index EGD
percentage of succession of procedure by endoscopist for immediate hemostasis of the culprit lesions causing upper gastrointestinal bleeding during index EGD
the need of second-look EGD
the need of second-look EGD
units of red cell transfusion
units of red cell transfusion within 24 hour
length of hospital stay
length of hospital stay
30-day rebleeding rate
30-day rebleeding rate

Full Information

First Posted
February 19, 2021
Last Updated
September 27, 2023
Sponsor
King Chulalongkorn Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04771481
Brief Title
Metoclopramide for Acute Upper GI Bleeding
Official Title
The Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Acute Upper Gastrointestinal Bleeding: Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
September 7, 2022 (Actual)
Study Completion Date
October 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Chulalongkorn Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Double-blind, Double centers, RCT All endoscopists at two participating sites attend the pre-study meeting for standardization of protocol and scoring system. Eligible patients were randomly assigned to either metoclopramide or placebo group in a 1:1 conceal allocation according to a computer-generated randomization list with block randomization in size of four. Assigned treatment was kept in opaque sealed envelopes. Before EGD, the patients had adequate resuscitation to maintain stable hemodynamics(SBP ≥ 90 mmHg and/or HR < 100 bpm) and blood transfusion to reach Hb> 7g/dL and correct coagulopathy. EGD is performed in left lateral position, under local lidocaine anesthesia alone or combined with IV anesthetics 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. To assess endoscopic gastric visualization, we applied simple validate objective scoring system and estimated coverage of blood clot on mucosa on reference endoscopies view in 4 locations, including fundus, corpus, antrum and duodenal bulb. Each location is scored between 0 and 2; Score 0 (worst vision) < 25% of the surface was visible; Score 1 25-75% visible surface; Score 2 (best vision), > 75% visible surface ( total score range 0-8) 'Adequate visualization' defined as total score six or higher (out of 8). All photos of endoscopic landmark, including the reference endoscopic views of four locations (fundus, corpus antrum and duodenal bulb), were taken and internally validated by another endoscopist who was blinded to the randomization allocation. The duration of the endoscopy was recorded from beginning to end of the procedure in minute. 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 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. 30-day rebleeding is accessed by direct phone call to patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Gastrointestinal Bleeding, Effect of Drug
Keywords
Metoclopramide, Acute upper gastrointestinal bleeding, Gastric visualization, Endoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
All participating endoscopists and patients were blinded to the randomization allocation.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metoclopramide
Arm Type
Experimental
Arm Description
Metoclopramide 10mg with normal saline up to 10 ml IV slowly push in 5minutes.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline 10 ml IV slowly push in 5 minutes.
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Intervention Description
Metoclopramide 10 mg + NSS 10 ml intravenous slowly push in 5min before endoscopy 30-120 min
Intervention Type
Drug
Intervention Name(s)
Normal Saline 10 mL Injection
Intervention Description
Normal saline 10 ml intravenous slowly push in 5min before endoscopy 30-120 min
Primary Outcome Measure Information:
Title
percentage of patents with 'adequate visualization'
Description
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
Time Frame
Though study completion , average 2 yr
Secondary Outcome Measure Information:
Title
mean difference in endoscopic visualized gastric score
Description
score 0-2, including total mean score , and at each location of fundus , corpus , antrum and duodenal bulb
Time Frame
Though study completion , average 2 yr
Title
duration of endoscopy
Description
duration of endoscopy
Time Frame
up to 2 hour
Title
immediate hemostasis at index EGD
Description
percentage of succession of procedure by endoscopist for immediate hemostasis of the culprit lesions causing upper gastrointestinal bleeding during index EGD
Time Frame
Though study completion , average 2 yr
Title
the need of second-look EGD
Description
the need of second-look EGD
Time Frame
72 hours
Title
units of red cell transfusion
Description
units of red cell transfusion within 24 hour
Time Frame
up to 30 days
Title
length of hospital stay
Description
length of hospital stay
Time Frame
up to 30days
Title
30-day rebleeding rate
Description
30-day rebleeding rate
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
King chulalongkorn memorial hospital
City
Bangkok
State/Province
Pathum Wan
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Division of Gastroenterology, Faculty of Medicine, Chulalongkorn University
City
Bangkok
State/Province
Pathumwan
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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Metoclopramide for Acute Upper GI Bleeding

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