ClinicalTrials.gov
ClinicalTrials.gov Menu

HDUPE 2004: Gastro-Oesophageal Haemorrhage in Emergency : Gastric Préparation to Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00259220
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : October 1, 2008
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Gastric lavage is usually used for gastric preparation before endoscopy in patients with upper gastrointestinal bleeding. However, the benefit-risk balance of putting a nasogastric tube in these patients is not clearly defined. This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid to put a gastric tube for the management of upper gastrointestinal bleeding.

Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Bleeding Drug: erythomycin Procedure: gastric lavage alone Procedure: erythromycine and gastric lavage Phase 3

Detailed Description:

Acute upper gastrointestinal haemorrhage is one of the main digestive emergencies involving hospital admission. Endoscopic examination plays a key role to determine the cause of the bleeding and to carry out a therapeutic procedure. Endoscopic performance depends on the quality of the examination that may be hampered by residual blood in the gastric cavity. Gastric lavage is usually performed to clear the stomach. However, several teams consider that it is possible to avoid putting a nasogastric tube because it is ineffective in half of the patients, disagreeable in most of them, can induce side effects and need a long time work for nurses. It could be replaced by the use of Erythromycin. There are no official recommendations in that field. Recent studies have shown that Erythromycin, a macrolide antibiotic with gastro kinetic properties can accelerate gastric emptying by inducing gastric contraction. This motilin receptor agonist could improve the gastric cleaning and the quality of endoscopic examination and decrease its duration.

This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid putting a gastric tube for the management of upper gastrointestinal bleeding. It is a prospective, controlled, randomized, multicentric study with a blind assessment of the main criteria. All patients aged more than 18 years with an acute upper gastrointestinal bleeding, defined by melena or hematemesis, managed by emergency department are enrolled. 270 patients are expected. Informed consent including for endoscopic examination and no contraindication for using Erythromycin (QT enlargement) is needed. Patients are randomized in three groups: Erythromycin alone, nasogastric tube with gastric lavage alone or both Erythromycin and nasogastric tube. Patients are followed-up until first month after bleeding. The main criteria are the visualization of the gastric tract and the other criteria are rebleeding until D 30, transfusion, gastric tube or erythromycin complications.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: In Urgency Hight Digestive Haemorrhage : Gastric Preparation for Endoscopy
Study Start Date : December 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: drug
erythromycine
Drug: erythomycin
erythomycin

2
gastric lavage alone
Procedure: gastric lavage alone
gastric lavage alone

Active Comparator: 3
erythromycine and gastric lavage
Procedure: erythromycine and gastric lavage
erythromycine and gastric lavage




Primary Outcome Measures :
  1. Endoscopic yield [ Time Frame: at the beggining of the study ]

Secondary Outcome Measures :
  1. Rebleeding until D 30, transfusion, gastric tube or erythromycin complications [ Time Frame: until 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hematemesis or melaena
  • No QT enlargement

Exclusion Criteria:

  • Refusing endoscopy
  • Glasgow < 15

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259220


Locations
France
Hôpital Jean VERDIER
Bondy, France, 93140
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Dominique PATERON, MD Assistance Publique - Hôpitaux de Paris

Responsible Party: Myriem CARRIER, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00259220     History of Changes
Other Study ID Numbers: P040427
AOM04093
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: October 1, 2008
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Bleeding
Endoscopy
Gastric tube
Erythromycin
Randomized

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action