Full Text View
Tabular View
No Study Results Posted
Related Studies
HDUPE 2004: Gastro-Oesophageal Haemorrhage in Emergency : Gastric Préparation to Endoscopy
This study has been completed.
Study NCT00259220   Information provided by Assistance Publique - Hôpitaux de Paris
First Received: November 28, 2005   Last Updated: September 30, 2008   History of Changes

November 28, 2005
September 30, 2008
December 2005
August 2008   (final data collection date for primary outcome measure)
Endoscopic yield [ Time Frame: at the beggining of the study ] [ Designated as safety issue: Yes ]
Endoscopic yield
Complete list of historical versions of study NCT00259220 on ClinicalTrials.gov Archive Site
Rebleeding until D 30, transfusion, gastric tube or erythromycin complications [ Time Frame: until 30 days ] [ Designated as safety issue: Yes ]
Rebleeding until D 30, transfusion, gastric tube or erythromycin complications
 
HDUPE 2004: Gastro-Oesophageal Haemorrhage in Emergency : Gastric Préparation to Endoscopy
In Urgency Hight Digestive Haemorrhage : Gastric Preparation for Endoscopy

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.

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.

Phase III
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Upper Gastrointestinal Bleeding
  • Drug: erythomycin
  • Procedure: gastric lavage alone
  • Procedure: erythromycine and gastric lavage
  • Experimental: erythromycine
  • Other: gastric lavage alone
  • Active Comparator: erythromycine and gastric lavage
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
270
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hematemesis or melaena
  • No QT enlargement

Exclusion Criteria:

  • Refusing endoscopy
  • Glasgow < 15
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00259220
Myriem CARRIER, Department Clinical Research of Developpement
P040427, AOM04093
Assistance Publique - Hôpitaux de Paris
 
Principal Investigator: Dominique PATERON, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP