Point-of-care Ultrasound Interest in Acute Gastrointestinal Bleeding Emergency Department Patients

NCT04436575 | Unknown

• 1 other identifier: TMarkarian/Ecuhda
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Acute Gastrointestinal (GI) Bleeding are a common chief complaint among Emergency Department. The mortality rate for Lower GI Bleeding is 3.9%. While the mortality rate can be as high as 10% for Upper GI Bleeding. Most existing scores take into account hemodynamic parameters such as systolic blood pressure or heart rate. Studies have shown that hemodynamic instability only develops late in the course of a bleed, as evidenced by a blood depletion of 30 to 40% of the total blood volume. Currently, few studies have examined the value of echocardiography in the management of patients presenting for Acute GI Bleeding in the Emergency Department. The main objective of this study is to show whether simple ultrasound parameters can, combined with clinico biological parameters, predict in an early manner the evolution of the patient presenting to the Emergency Department for Acute Gastrointestinal Bleeding.

Conditions

Acute Gastrointestinal Bleeding

Keywords

emergency department; acute gastrointestinal bleeding; echocardiography

Outcome Measures

Primary Outcomes (1)

• Correlation of ultrasound parameters with the occurrence of adverse events

  The primary outcome was to determine the correlation of echocardiography parameters to detect adverse events (AEs). Echocardiography parameters included signs of severe hypovolemia (end systolic left ventricular obliteration and/or complete inspiratory collapse of the inferior vena cava and/or E velocity \< 0.7 m/s). Adverse events were defined as blood transfusion, therapeutic intervention to control haemorrhage (endoscopic, radiologic or surgical hemostasis), rebleeding and in-hospital mortality.

  1 day

Secondary Outcomes (2)

• Echocardiography and clinical scores

  1 day

• Other ultrasound parameters with the occurrence of adverse events

  1 day

Interventions

Point-of-care ultrasound DEVICE

Point-of-care ultrasound prognostic performance : echocardiography mainly

Also known as: Echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients managed in investigative emergency department whose primary reason for management is acute gastrointestinal bleeding may be included. Patients with echocardiography are included.

You may qualify if:

• Primary reason for emergency Department admission is acute gastrointestinal bleeding

You may not qualify if:

• Pregnant or breastfeeding women
• Persons not benefiting from a social security scheme
• Persons deprived of liberty
• Patient participates in another study
• The patient is under legal protection, guardianship or trusteeship.
• Patient refuses to participate
• It proves impossible to give informed information about the subject matter
• The patient is not fluent in French.

Sponsors & Collaborators

• SUD Association pour le Développement de la Recherche et de lEnseignement: lead

Study Sites (1)

MARKARIAN Thibaut

Marseille, France

Location

MeSH Terms

Conditions

Emergencies

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 18, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: November 1, 2021
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)