Clinical trial NCT00689754: Efficacy and Safety Study on Nasogastric (NG) Tube in Patients With Upper Gastrointestinal Bleed
Official title: The Role of Routine Placement of Nasogastric Tube in Patients With Suspected Upper Gastrointestinal Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Hemorrhage
Liver Cirrhosis
Keywords: gastrointestinal hemorrhage
gastrointestinal intubation
endoscopy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 282
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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)

Primary outcomes:
measure: The number of patients predicted accurately to have a treatable lesion
timeFrame: 24h
Secondary outcomes:
measure: Complications of nasogastric aspiration and lavage
timeFrame: 24h
measure: Relationship between time to endoscopy and upper gastrointestinal hemorrhage
timeFrame: 24h
measure: Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused
timeFrame: 24h
measure: Complication of nasogastric tube placement and aspiration in cirrhotics
timeFrame: 24h
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Silvio W Melo, MD
role: PRINCIPAL_INVESTIGATOR
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