- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04196504
Prevalence of Echocardioghraphic and ECG Changes in Patients With Acute Pancreatitis and Its Impact on Outcome.
December 10, 2019 updated by: Alaaeldin Mahmoud Ibrahim Abdelrahman, Assiut University
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.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- all patients with acute pancreatitis aged more than 18 yrs admitted to Al-raghy ICU of all etiologies
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at admission on 1st day
|
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
|
though out hospital admission (an average of 1 week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mahmoud Ashry, professor, Assiut University
- Study Director: Lobna Abdelwahid, assistant professor, Assiut University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 31, 2019
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
October 12, 2019
First Submitted That Met QC Criteria
December 10, 2019
First Posted (Actual)
December 12, 2019
Study Record Updates
Last Update Posted (Actual)
December 12, 2019
Last Update Submitted That Met QC Criteria
December 10, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Echo_ECG_pancreatitis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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