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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

Tracking Information
First Submitted Date July 23, 2019
First Posted Date July 26, 2019
Last Update Posted Date November 5, 2019
Estimated Study Start Date November 15, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2019)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04033549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 23, 2019)
  • 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
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Thoracic Ultrasound on Acute Pancreatitis
Official Title Utility of Thoracic Ultrasound in Patients With Acute Pancreatitis as a Prognostic Tool of Respiratory Dysfunction and Severity
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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Acute Pancreatitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 23, 2019)
46
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
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
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04033549
Other Study ID Numbers GA18-00005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party Dr. med. Hector Eloy Tamez Perez, Hospital Universitario Dr. Jose E. Gonzalez
Study Sponsor Hospital Universitario Dr. Jose E. Gonzalez
Collaborators Not Provided
Investigators
Principal Investigator: Jesus Cuellar Monterrubio, M.D. Universidad Autonoma de Nuevo Leon
PRS Account Hospital Universitario Dr. Jose E. Gonzalez
Verification Date November 2019