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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Silvio Melo, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00689754
First received: June 2, 2008
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Gastrointestinal Hemorrhage
Liver Cirrhosis
Procedure: nasogastric tube placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Role of Routine Placement of Nasogastric Tube in Patients With Suspected Upper Gastrointestinal Hemorrhage

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • The number of patients predicted accurately to have a treatable lesion [ Time Frame: 24h ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complications of nasogastric aspiration and lavage [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
  • Relationship between time to endoscopy and upper gastrointestinal hemorrhage [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
  • Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
  • Complication of nasogastric tube placement and aspiration in cirrhotics [ Time Frame: 24h ] [ Designated as safety issue: Yes ]

Enrollment: 282
Study Start Date: January 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NGA
Patients will receive the standard of care to proceed with nasogastric tube placement, aspiration and lavage up to 1L of normal saline
Procedure: nasogastric tube placement
standard nasogastric tube placement, aspiration and lavage up to 1L of normal saline
No Intervention: NO NGA
Patient presenting with Upper GI hemorrhage going straight to endoscopy.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00689754

Locations
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Silvio W Melo, MD UT Southwestern Medical Center at Dallas
  More Information

Additional Information:
Publications:

Responsible Party: Silvio Melo, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00689754     History of Changes
Other Study ID Numbers: 102007-022
Study First Received: June 2, 2008
Last Updated: November 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
gastrointestinal hemorrhage
gastrointestinal intubation
endoscopy

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

ClinicalTrials.gov processed this record on July 22, 2014