Efficacy and Safety Study on Nasogastric (NG) Tube in Patients With Upper Gastrointestinal Bleed

Not Applicable

Completed

• Conditions: Gastrointestinal Hemorrhage; Liver Cirrhosis
• Interventions: Procedure: nasogastric tube placement

• Registration Number: NCT00689754
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

Upper gastrointestinal tract hemorrhage (UGIH) remains a major cause of morbidity and mortality . Nasogastric aspiration (NGA) is routinely performed in patients with UGIH to obtain important clinical data and make therapeutic decisions. But routine use of NGA remains controversial with studies reporting its usefulness and its redundant clinical information. Early esophagogastroduodenoscopy (EGD) is recommended by most gastrointestinal societies to allow for risk stratification and to perform endoscopic treatments. The results of the NGA may assist to differentiate between high-risk versus low-risk lesions. Our hypothesis is that presence of NGA can identify lesions that require endoscopic treatment and provides important clinical information to guide the treating physician. In addition, we hypothesized that the results of the NGA influence the clinical decision of the treating physician regarding the prediction of the need for endoscopic therapy. This observational randomized cross-sectional study will enroll consecutive patients with presumed UGIH and randomized them to NGA and no NGA recording its results. All patients will receive an EGD and its results will also be recorded. Subsequently, we will evaluate if the NGA is important in identifying endoscopically significant lesions. The information gained will help guide clinicians evaluating patient with UGIH.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-16
• Last Update Posted: 2011-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• Patients older then 21 years-old presenting with actual or reported: Hematemesis, Melena, or Hematemesis and Melena

Exclusion Criteria

• Refusal to participate
• Severe comorbid conditions making EGD hazardous for the patient, such as myocardial infarction < 3 months with the exception if the myocardial infarction was caused by the UGIH, hemorrhagic or ischemic stroke < 3 months, decompensated congestive heart failure, severe respiratory failure unless the patient is already intubated
• Survival expected to be less than 72h as judged by treating clinician
• Prisoners
• Patient with severe mental illness precluding the ability to obtain informed consent
• Ongoing anticoagulation which can not be reversed secondary to patient safety
• Strongly suspected gastrointestinal perforation
• Recent endoscopy (less than 30 days)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NGA	nasogastric tube placement	Patients will receive the standard of care to proceed with nasogastric tube placement, aspiration and lavage up to 1L of normal saline

Primary Outcome Measures

Name	Time	Method
The number of patients predicted accurately to have a treatable lesion	24h

Secondary Outcome Measures

Name	Time	Method
Complications of nasogastric aspiration and lavage	24h
Relationship between time to endoscopy and upper gastrointestinal hemorrhage	24h
Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused	24h
Complication of nasogastric tube placement and aspiration in cirrhotics	24h

Trial Locations

Locations (1)

Parkland Memorial Hospital; 🇺🇸 Dallas, Texas, United States