NCT04033549

Brief Summary

Authors design a prospective, longitudinal, descriptive study to identify the findings of thoracic point-of-care ultrasound in patients with acute pancreatitis. Patients will be included in the study since August through December 2019, admitted to the University Hospital, "Dr. José E. González", Universidad Autonoma de Nuevo León. These patients will undergo a pulmonary and vena cava ultrasound at admission, at 24 and 48 hours. The authors will describe findings of pulmonary ultrasound and their correlation with severity in patients with acute pancreatitis of all etiologies. The authors will analyze variables such Systemic inflammatory response syndrome, severity according to the revised Atlanta criteria (2012), and systemic complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

July 23, 2019

Last Update Submit

January 3, 2020

Conditions

Keywords

Acute pancreatitisThoracic ultrasound

Outcome Measures

Primary Outcomes (1)

  • B-type lines on thoracic point-of-care ultrasound in patients with acute pancreatitis

    The number of B-type lines measured by thoracic point-of-care ultrasound in patients with acute pancreatitis.

    48 hours

Secondary Outcomes (4)

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

    48 hours

  • B-type lines and Atlanta score in patients with acute pancreatitis

    48 hours

  • Inferior vena cava diameter and Atlanta score in patients with acute pancreatitis

    48 hours

  • Inferior vena cava diameter and 48 hours mortality in patients with acute pancreatitis

    7 days

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that attend the Emergency department of Hospital Universitario, "Dr. José Eleuterio González" U.A.N.L, with a diagnosis of acute pancreatitis of all causes

You may qualify if:

  • Patients with diagnosis of acute pancreatitis by means of clinical presentation, laboratory results and/or imaging.
  • Both genders.
  • All etiologies of pancreatitis.
  • Ages above 18.

You may not qualify if:

  • History of acute pancreatitis in prior 12 months.
  • Patients with referrals from other institutions.
  • Patients with other chronic comorbidities such as renal or cardiac insufficiency.
  • Patients with acute pancreatitis and high suspicion of cholangitis.
  • Patients with acute pancreatitis and acute cholecystitis.
  • Pregnant patients with acute pancreatitis.
  • Patients who decline being part of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Jesus Cuellar Monterrubio, 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

July 23, 2019

First Posted

July 26, 2019

Study Start

November 15, 2019

Primary Completion

December 30, 2019

Study Completion

December 31, 2019

Last Updated

January 6, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

If need information will be available upon email contact request.

Shared Documents
STUDY PROTOCOL
Time Frame
1 year
Access Criteria
email contact request for academic purposes

Locations