Acute PancreatitisECOPANCNCT04033549
Thoracic Ultrasound on Acute Pancreatitis
An observational study of Acute Pancreatitis, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 49 participants
- Where
- 1 siteMexico
- Study dates
- 15 Nov 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr. Jose E. Gonzalez, Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460
About this study
Official title: Utility of Thoracic Ultrasound in Patients With Acute Pancreatitis as a Prognostic Tool of Respiratory Dysfunction and Severity
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.
Read the 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
- 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.
- Secondary objectives:
- to correlate the number of B-type lines measured by thoracic point-of-care ultrasound with severity in patients with acute pancreatitis.
- to correlate the diameter in centimeters of inferior vena cava measured by thoracic point-of-care ultrasound with severity in patients with acute pancreatitis
- 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
- 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:
- 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.
- 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.
- Conditions
- Acute Pancreatitis
- Keywords
- Acute pancreatitis, Thoracic ultrasound
- Medical subject headings
- Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Secondary outcomes (4)
Diameter of inferior vena cava on thoracic point-of-care ultrasound in patients with acute pancreatitis.
The diameter in centimeters of inferior vena cava measured by thoracic point-of-care ultrasound in patients with acute pancreatitis
Measured: 48 hours
B-type lines and Atlanta score in patients with acute pancreatitis
To correlate the presence of B-type lines on thoracic point-of-care ultrasound with Atlanta score in patients with acute pancreatitis
Measured: 48 hours
Inferior vena cava diameter and Atlanta score in patients with acute pancreatitis
To correlate the inferior vena cava diameter with the Atlanta score in patients with acute pancreatitis
Measured: 48 hours
Inferior vena cava diameter and 48 hours mortality in patients with acute pancreatitis
To correlate the inferior vena cava diameter with the 48 hours post-admission mortality rate in patients with acute pancreatitis.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start15 Nov 2019
- Primary completion30 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Hector Eloy Tamez Perez, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Jesus Cuellar Monterrubio, M.D., Principal investigator, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033549
- Sponsor's protocol ID
- GA18-00005
- Acronym
- ECOPANC
- Status last verified
- Jan 2020
- First submitted
- 23 Jul 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If need information will be available upon email contact request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Thoracic Ultrasound in Patients With Acute Pancreatitis as a Prognostic Tool of Respiratory Dysfunction and Severity
- ClinicalTrials.gov ID
- NCT04033549
- Acronym / sponsor ID
- ECOPANC / GA18-00005
- Conditions
- Acute Pancreatitis
- Keywords
- Acute pancreatitis, Thoracic ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- Secondary objectives:
- to correlate the number of B-type lines measured by thoracic point-of-care ultrasound with severity in patients with acute pancreatitis.
- to correlate the diameter in centimeters of inferior vena cava measured by thoracic point-of-care ultrasound with severity in patients with acute pancreatitis
- 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
- 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:
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Diameter of inferior vena cava on thoracic point-of-care ultrasound in patients with acute pancreatitis.
Time frame: 48 hours
B-type lines and Atlanta score in patients with acute pancreatitis
Time frame: 48 hours
Inferior vena cava diameter and Atlanta score in patients with acute pancreatitis
Time frame: 48 hours
Inferior vena cava diameter and 48 hours mortality in patients with acute pancreatitis
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Individual participant dataSharing planned: Yes. If need information will be available upon email contact request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus Cuellar Monterrubio, M.D. principal investigator
Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B-type lines on thoracic point-of-care ultrasound in patients with acute pancreatitis (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.