Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Thoracic Ultrasound on Upper Gastrointestinal Bleeding (ECOBLEDSTUDY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03944148
Recruitment Status : Completed
First Posted : May 9, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. med. Hector Eloy Tamez Perez, Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary:

Upper Gastrointestinal bleeding (UGIB) is a medical emergency and the most common cause of hospitalization associated with digestive disease. Proper initial resuscitation is the first step in the management of UGIB patients. Today, modern pulmonary ultrasound is used in different clinical settings, such as intensive care, emergency medicine and/or traumatology. In the last years, the use of this has been standardized both in internal medicine and in pulmonary medicine. The primary objective is to describe the findings of pulmonary ultrasound and its relationship with severity in patients with UGIB. The investigators will include all patients with UGIB. A pulmonary and vena cava ultrasound will be performed on admission to the emergency room, 10 minutes prior to endoscopy and 24 hours after having performed the endoscopy.

The use of thoracic point-of-care ultrasound (TPOCUS) has been standardized in both internal and pulmonary medicine. There is a concern about the role of TPOCUS useful as a severity prognostic tool in patients with UGIB.

The team proposes that TPOCUS is a severity prognostic tool in UGIB patients.

Main Outcome: To describe the findings of TPOCUS in patients with variceal and non-variceal UGIB.

Secondary Objectives:

  1. Correlate the presence of B-type lines on TPOCUS with mean arterial pressure in UGIB patients.
  2. Correlate the inferior vena cava diameter with the Model for End-stage Liver Disease scale in UGIB patients.
  3. Correlate the inferior vena cava diameter with the 48 hours post-admission mortality of UGIB patients.

Authors design a prospective, longitudinal, descriptive study to identify the findings of TPOCUS in patients with variceal and non-variceal UGIB. Patients will be included in the study since May 15th through October 30th 2019, admitted to the University Hospital, "Dr. José E. González", Universidad Autónoma de Nuevo León.


Condition or disease
Upper Gastrointestinal Bleeding

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Thoracic Point of Care Ultrasound on Initial Management of Upper Gastrointestinal Bleeding
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. B-type lines on thoracic point-of-care ultrasound in patients with UGIB. [ Time Frame: 48 hours ]
    The number of B-type lines measured by thoracic point-of-care ultrasound in patients with variceal and non-variceal UGIB at 48 hours.

  2. Diameter of inferior vena cava on thoracic point-of-care ultrasound in patients with UGIB. [ Time Frame: 48 hours ]
    The diameter in centimeters of inferior vena cava measured by thoracic point-of-care ultrasound in patients with variceal and non-variceal UGIB at 48 hours.


Secondary Outcome Measures :
  1. B-type lines and mean arterial pressure on UGIB patients [ Time Frame: 48 hours ]
    To correlate the presence of B-type lines on thoracic point-of-care ultrasound with mean arterial pressure in UGIB patients.

  2. Inferior vena cava diameter and Model for End-stage Liver Disease on UGIB patients [ Time Frame: 48 hours ]
    To correlate the inferior vena cava diameter with the Model for End-stage Liver Disease scale in UGIB patients.

  3. Inferior vena cava diameter and 48 hours mortality in UGIB patients. [ Time Frame: 48 hours ]
    To correlate the inferior vena cava diameter with the 48 hours post-admission mortality rate in UGIB patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with variceal and non-variceal UGIB, who arrive to the emergency department of the University Hospital, "Dr. José E. González" Universidad Autónoma de Nuevo León.
Criteria

Inclusion Criteria:

  • Age, more than 17 years old.
  • Patients diagnosed with UGIB.
  • Any etiology of the UGIB.

Exclusion Criteria:

  • Patients with UGIB previously treated in other hospitals.
  • Patients with UGIB with Blatchford scale less than 2 points.
  • Pregnant women.
  • Refusal to participate in the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944148


Locations
Layout table for location information
Mexico
Hospital Universitario Dr. Jose E. Gonzalez, Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Layout table for investigator information
Principal Investigator: Hector Ibarra Sifuentes, M.D. Universidad Autonoma de Nuevo Leon

Layout table for additonal information
Responsible Party: Dr. med. Hector Eloy Tamez Perez, Clinical Professor, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT03944148    
Other Study ID Numbers: G19-00001
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: If need information will be available upon email contact request.
Supporting Materials: Study Protocol
Time Frame: 1 year
Access Criteria: email contact request for academic purposes.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. med. Hector Eloy Tamez Perez, Hospital Universitario Dr. Jose E. Gonzalez:
Upper Gastrointestinal Bleeding
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases