Acute PancreatitisNCT04196504
Prevalence of Echocardioghraphic and ECG Changes in Patients With Acute Pancreatitis and Its Impact on Outcome.
An observational study of Acute Pancreatitis, run by Assiut University.
Trial summary
Cardiovascular system involvement with acute pancreatitis has been described before in the form of ECG changes and echocardiographic findings. However the correlation between these changes and the outcome of acute pancreatitis has not been and whether they can be used to predict mortality in these patients has been… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Echocardiograghy, ECG
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2019to 31 Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients with acute pancreatitis aged more than 18 yrs \& less than 80 years old not known cardiac and with no pre-existing diabetes, chronic renal failure or malignancy with no hx of chronic pancreatitis admitted to Al-raghy ICU of all etiologies
Who may be able to join
- all patients with acute pancreatitis aged more than 18 yrs admitted to Al-raghy ICU of all etiologies
Who cannot join
- patients less that 18 years
- patients above 80 years
- patients with known cardiac disease
- patients with pre-existing diabetes, chronic renal failure or malignancy.
- patients with underlying chronic pancreatitis
Trial locations and contacts
No sites are listed yet.
About this study
Cardiovascular system involvement with acute pancreatitis has been described before in the form of ECG changes and echocardiographic findings. However the correlation between these changes and the outcome of acute pancreatitis has not been and whether they can be used to predict mortality in these patients has been controversial.In the current study our aim is to detect echocardioghraphic and ECG changes in acute pancreatitis and investigate the significance of these changes on prognosis.
Read the detailed description
Acute pancreatitis is a relatively common disease with significant morbidity and mortality. About 75% of pancreatitis is caused by gallstones or alcohol. The Atlanta classification of acute pancreatitis has been used to differentiate between severe and mild cases of acute pancreatitis. According to this classification, patients are diagnosed with severe acute pancreatitis if they show evidence of organ failure, Local complications (eg, necrosis, abscess, pseudocyst), Ranson score of 3 or higher or APACHE score of 8 or higher. Severe acute pancreatitis has a wide range of affection on nearly all body systems with various degrees of affection than affect both the clinical picture and the prognosis of the disease. the cardiovascular system involvement has been described before ,in the form of ECG changes (sinus tachycardia, arrhythmias, conduction abnormalities.. ) and echocardiographic findings (diastolic,systolic or combined dysfunction, wall motion abnormalities, pericardial effusion..). However the correlation between these changes and the outcome of acute pancreatitis has not been and whether they can be used to predict mortality in these patients has been controversial.In the current study our aim is to detect echocardioghraphic and ECG changes in acute pancreatitis and investigate the significance of these changes on prognosis.
- Conditions
- Acute Pancreatitis
- Being tested
- Echocardiograghy, ECG
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiograghy, ECGDevice
transthoracic echocariography, 12 lead ECG
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic (mainly diastolic dysfunction & pericardial effusion) and ECG changes (mainly QT interval) in patients with acute pancreatitis.
To detect the echocardiographic (mainly diastolic dysfunction \& pericardial effusion) and ECG changes (mainly QT interval) in patients with acute pancreatitis.
Measured: at admission on 1st day
determine the impact of these changes on outcome of patients
determine the impact of these changes on outcome of patients
Measured: though out hospital admission (an average of 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start31 Dec 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaaeldin Mahmoud Ibrahim Abdelrahman, Assiut University
- Investigators
- Mahmoud Ashry, professor, Study chair, Assiut UniversityLobna Abdelwahid, assistant professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196504
- Sponsor's protocol ID
- Echo_ECG_pancreatitis
- Status last verified
- Dec 2019
- First submitted
- 12 Oct 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Echocardioghraphic and ECG Changes in Patients With Acute Pancreatitis and Its Impact on Outcome.
- ClinicalTrials.gov ID
- NCT04196504
- Acronym / sponsor ID
- Echo_ECG_pancreatitis
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Dec 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 12 Dec 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.
Cardiovascular system involvement with acute pancreatitis has been described before in the form of ECG changes and echocardiographic findings. However the correlation between these changes and the outcome of acute pancreatitis has not been and whether they can be used to predict mortality in these patients has been controversial.In the current study our aim is to detect echocardioghraphic and ECG changes in acute pancreatitis and investigate the significance of these changes on prognosis.
Detailed description
Acute pancreatitis is a relatively common disease with significant morbidity and mortality. About 75% of pancreatitis is caused by gallstones or alcohol. The Atlanta classification of acute pancreatitis has been used to differentiate between severe and mild cases of acute pancreatitis. According to this classification, patients are diagnosed with severe acute pancreatitis if they show evidence of organ failure, Local complications (eg, necrosis, abscess, pseudocyst), Ranson score of 3 or higher or APACHE score of 8 or higher. Severe acute pancreatitis has a wide range of affection on nearly all body systems with various degrees of affection than affect both the clinical picture and the prognosis of the disease. the cardiovascular system involvement has been described before ,in the form of ECG changes (sinus tachycardia, arrhythmias, conduction abnormalities.. ) and echocardiographic findings (diastolic,systolic or combined dysfunction, wall motion abnormalities, pericardial effusion..). However the correlation between these changes and the outcome of acute pancreatitis has not been and whether they can be used to predict mortality in these patients has been controversial.In the current study our aim is to detect echocardioghraphic and ECG changes in acute pancreatitis and investigate the significance of these changes on prognosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with acute pancreatitis aged more than 18 yrs \& less than 80 years old not known cardiac and with no pre-existing diabetes, chronic renal failure or malignancy with no hx of chronic pancreatitis admitted to Al-raghy ICU of all etiologies
Key inclusion criteria (1 listed)
- all patients with acute pancreatitis aged more than 18 yrs admitted to Al-raghy ICU of all etiologies
Key exclusion criteria (5 listed)
- patients less that 18 years
- patients above 80 years
- patients with known cardiac disease
- patients with pre-existing diabetes, chronic renal failure or malignancy.
- patients with underlying chronic pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiograghy, ECGtransthoracic echocariography, 12 lead ECG | Device | – |
Primary outcome
Echocardiographic (mainly diastolic dysfunction & pericardial effusion) and ECG changes (mainly QT interval) in patients with acute pancreatitis.
Time frame: at admission on 1st day
To detect the echocardiographic (mainly diastolic dysfunction \& pericardial effusion) and ECG changes (mainly QT interval) in patients with acute pancreatitis.
determine the impact of these changes on outcome of patients
Time frame: though out hospital admission (an average of 1 week)
determine the impact of these changes on outcome of patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Mahmoud Ashry, professor study chair
Assiut University
Lobna Abdelwahid, assistant professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Assiut University.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaaeldin M. Abdelrahman, MBBS (01144780935 ext. +2, aladdinmahmoud@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic (mainly diastolic dysfunction & pericardial effusion) and ECG changes (mainly QT interval) in patients with acute pancreatitis. (time frame: at admission on 1st day). The study lists 2 primary outcomes in all. 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 12 Dec 2019.