Thoracic Ultrasound on Upper Gastrointestinal Bleeding (ECOBLEDSTUDY)

NCT03944148 | Completed DMC

• 1 other identifier: G19-00001
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Upper Gastrointestinal Bleeding

Keywords

Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (2)

• B-type lines on thoracic point-of-care ultrasound in patients with UGIB.

  The number of B-type lines measured by thoracic point-of-care ultrasound in patients with variceal and non-variceal UGIB at 48 hours.

  48 hours

• Diameter of inferior vena cava on thoracic point-of-care ultrasound in patients with UGIB.

  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.

  48 hours

Secondary Outcomes (3)

• B-type lines and mean arterial pressure on UGIB patients

  48 hours

• Inferior vena cava diameter and Model for End-stage Liver Disease on UGIB patients

  48 hours

• Inferior vena cava diameter and 48 hours mortality in UGIB patients.

  48 hours

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. Jose E. Gonzalez, Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hector Ibarra Sifuentes, M.D.

  Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 9, 2019
• Study Start: July 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year
• Access Criteria: email contact request for academic purposes.

Locations

ME (1)