Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259220
Status:
COMPLETED
Last Update Posted:
2008-10-01
First Post:
2005-11-28
Brief Title:
HDUPE 2004 Gastro-Oesophageal Haemorrhage in Emergency Gastric Préparation to Endoscopy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
In Urgency Hight Digestive Haemorrhage Gastric Preparation for Endoscopy
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOM04093 | None | None | None |