NCT04196504

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

December 31, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

October 12, 2019

Last Update Submit

December 10, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    though out hospital admission (an average of 1 week)

Interventions

transthoracic echocariography, 12 lead ECG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • all patients with acute pancreatitis aged more than 18 yrs admitted to Al-raghy ICU of all etiologies

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatitis

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Mahmoud Ashry, professor

    Assiut University

    STUDY CHAIR
  • Lobna Abdelwahid, assistant professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Alaaeldin M. Abdelrahman, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2019

First Posted

December 12, 2019

Study Start

December 31, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 12, 2019

Record last verified: 2019-12