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Thoracic Ultrasound on Acute Pancreatitis (ECOPANC)

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ClinicalTrials.gov Identifier: NCT04033549
Recruitment Status : Not yet recruiting
First Posted : July 26, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. med. Hector Eloy Tamez Perez, Hospital Universitario Dr. Jose E. Gonzalez

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.

Condition or disease
Acute Pancreatitis

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Detailed Description:

Acute pancreatitis has been described as the most common cause of pancreatic disease with a global incidence of 33-74 per 100.000 people and a mortality of 1-16 per 100.000. Hydration with the purpose of preventing hypovolemia and hypoperfusion of organs is the cornerstone of initial disease management. "Aggressive" hydration, has been based on animal models and observational data from clinical studies, and has been associated with respiratory complications, compartment syndrome, sepsis, and mortality. Nowadays pulmonary ultrasound has been used in a wide array of clinical settings such as intensive care unit, emergency medicine, and nephrology. It has been a standardized tool in internal and pulmonary medicine.

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.

OBJECTIVES

  1. Primary objective:

    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.

  2. Secondary objectives:

    1. to correlate the number of B-type lines measured by thoracic point-of-care ultrasound with severity in patients with acute pancreatitis.
    2. to correlate the diameter in centimeters of inferior vena cava measured by thoracic point-of-care ultrasound with severity in patients with acute pancreatitis
    3. to correlate the inferior vena cava diameter with the 48 hours post-admission mortality rate in patients with acute pancreatitis.

STUDY DESIGN Prospective, transversal, descriptive.

SUBJECTS AND METHODS

  1. Patients:

    In the time period of August 2019 through December 2019 the authors will include patients with pancreatitis.

    The investigators will include all 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.

    Inclusion criteria:

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

    Exclusion criteria:

    1. History of acute pancreatitis in prior 12 months.
    2. Patients with referrals from other institutions.
    3. Patients with other chronic comorbidities such as renal or cardiac insufficiency.
    4. Patients with acute pancreatitis and high suspicion of cholangitis.
    5. Patients with acute pancreatitis and acute cholecystitis.
    6. Pregnant patients with acute pancreatitis.
    7. Patients who decline being part of this study.
  2. Methods:

The investigators will study all patients who come to the emergency room of the hospital with diagnosis of Acute Pancreatitis. Patients will undergo a pulmonary and vena cava ultrasound at admission, at 24 and 48 hours.

Ultrasound will be performed bilateral intercostal with the patient in supine decubitus with the head at 30 degrees, after the application of acoustic gel on the skin. To improve imaging, the intercostal spaces will be extended by raising the ipsilateral arm of each patient to the level of the head or above it during the procedure.

Each hemithorax is divided into 4 areas: anterior and lateral, superior and inferior. For each hemithorax, the anterior area was delineated between the clavicle and the diaphragm and from the parasternal line to the anterior axillary line. The lateral area was delineated between the axilla and the diaphragm and from the anterior to the posterior axillary line. The upper quadrants were demarcated from the 1st to the 3rd intercostal space and the lower quadrants from the 4th to the 6th intercostal space. A total of 8 areas of the chest will be visualized during normal breathing.

Findings that will be reported upon pulmonary ultrasound:

B lines: They are hydro-aerial artifacts in comet tail image, begin at the pleural line, are hyperechoic, well defined, disseminated towards the end of the screen, delete A lines , and accompany pleural movements.

The lines separated from each other around 7 mm correspond to interstitial edema, while those that distance 3 mm indicate the presence of alveolar edema. The presence of more than 3 B lines indicate the presence of an alveolar-interstitial syndrome.

Pleural effusion: It is visualized as a space free of echoes (anechoic image, "black") between the visceral pleura (pulmonary line), together with the parietal pleura (pleural line) and the shadow of the ribs. In M mode, the movement of the lung line or the visceral pleura to the pleural line or the parietal pleura upon inspiration is shown, creating the sinusoidal sign.

Measurement of the inferior Vena cava:

Intravascular volume status will be assessed by measuring the diameter and percentage of collapse of the inferior vena cava. It is performed in the subxiphoid window with the identification of the four cardiac chambers, then a 90º turn of the transducer is made in the cephalad direction, which shows the right atrium, the mouth of the vena cava and the hepatic gland above it. To measure its diameter, it will be beyond the confluence point of the hepatic veins, which is usually found approximately 2 cm from the mouth of the inferior vena cava-right atrium. Based on the measurement and collapse of the IVC, volemic state will be defined in a patient with spontaneous breathing as follows: a diameter of the Inferior cava vein <2 cm that collapses> 50% suggests lack of volume; however, a diameter of the Inferior cava vein > 2 cm that collapses <50% suggests a hypervolemic state.

The authors will analyze variables such Systemic inflammatory response syndrome, severity according to the revised Atlanta criteria (2012), and systemic complications.


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Study Type : Observational
Estimated Enrollment : 46 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Utility of Thoracic Ultrasound in Patients With Acute Pancreatitis as a Prognostic Tool of Respiratory Dysfunction and Severity
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 31, 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 acute pancreatitis [ Time Frame: 48 hours ]
    The number of B-type lines measured by thoracic point-of-care ultrasound in patients with acute pancreatitis.


Secondary Outcome Measures :
  1. Diameter of inferior vena cava on thoracic point-of-care ultrasound in patients with acute pancreatitis. [ Time Frame: 48 hours ]
    The diameter in centimeters of inferior vena cava measured by thoracic point-of-care ultrasound in patients with acute pancreatitis

  2. B-type lines and Atlanta score in patients with acute pancreatitis [ Time Frame: 48 hours ]
    To correlate the presence of B-type lines on thoracic point-of-care ultrasound with Atlanta score in patients with acute pancreatitis

  3. Inferior vena cava diameter and Atlanta score in patients with acute pancreatitis [ Time Frame: 48 hours ]
    To correlate the inferior vena cava diameter with the Atlanta score in patients with acute pancreatitis

  4. Inferior vena cava diameter and 48 hours mortality in patients with acute pancreatitis [ Time Frame: 7 days ]
    To correlate the inferior vena cava diameter with the 48 hours post-admission mortality rate in patients with acute pancreatitis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT04033549


Contacts
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Contact: Jesus Cuellar Monterrubio, M.D. +52 83891111 ext 2198 lalo_2902@hotmail.com
Contact: Hector Ibarra Sifuentes, M.D. +52 83891111 ext 3192 hraulibas@gmail.com

Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
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Principal Investigator: Jesus Cuellar Monterrubio, M.D. Universidad Autonoma de Nuevo Leon

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Responsible Party: Dr. med. Hector Eloy Tamez Perez, Clinical Professor, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT04033549     History of Changes
Other Study ID Numbers: GA18-00005
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 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

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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:
Acute pancreatitis
Thoracic ultrasound
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases