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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00259220
First received: November 28, 2005
Last updated: September 30, 2008
Last verified: March 2007
  Purpose

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 Intervention Phase
Upper Gastrointestinal Bleeding
Drug: erythomycin
Procedure: gastric lavage alone
Procedure: erythromycine and gastric lavage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: In Urgency Hight Digestive Haemorrhage : Gastric Preparation for Endoscopy

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Endoscopic yield [ Time Frame: at the beggining of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rebleeding until D 30, transfusion, gastric tube or erythromycin complications [ Time Frame: until 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 270
Study Start Date: December 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: drug
erythromycine
Drug: erythomycin
erythomycin
Other Name: erythomycin
2
gastric lavage alone
Procedure: gastric lavage alone
gastric lavage alone
Other Name: gastric lavage alone
Active Comparator: 3
erythromycine and gastric lavage
Procedure: erythromycine and gastric lavage
erythromycine and gastric lavage
Other Name: erythromycine and gastric lavage

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hematemesis or melaena
  • No QT enlargement

Exclusion Criteria:

  • Refusing endoscopy
  • Glasgow < 15
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Myriem CARRIER, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00259220     History of Changes
Other Study ID Numbers: P040427, AOM04093
Study First Received: November 28, 2005
Last Updated: September 30, 2008
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014