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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06351956
Other study ID # Arrhythmias in Septic Patients
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 20, 2024
Est. completion date December 30, 2026

Study information

Verified date April 2024
Source Assiut University
Contact Dina Sameh, Bachelor's
Phone 01211947776
Email dinakoka96@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes


Description:

Sepsis is recently defined as life-threatening condition caused by dysregulated body response to infection leading to organ dysfunction and even death. Patients who are vulnerable to catch sepsis are those with immune-compromising diseases, old aged people and chronic medical condition such as diabetes, chronic kidney diseases or cancer. Sepsis is symptomized by fever or hypothermia, tachycardia, tachypnea. In critical care units, septic patient are predisposed to have different cardiovascular manifestation as atrial fibrillation, atrial flutter, hypotension, etc. . Many studies reported the association between atrial fibrillation and septic patients in critical care as a complication of sepsis; but data regarding factors and fates is still insufficient. So in this study we aim to observe critical ill patients with sepsis to assess and evaluate the predisposing factors leading to new onset of cardiac arrhythmia in septic patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 72
Est. completion date December 30, 2026
Est. primary completion date April 20, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Adult patient of 18 years old and above of both gender admitted with manifestation of sepsis. Exclusion Criteria: - Patients below 18 years old. - Pregnant females. - Patients with cardiac arrhythmia before admission in the critical unit. - Patients with previous cardiac surgery.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Makrygiannis SS, Margariti A, Rizikou D, Lampakis M, Vangelis S, Ampartzidou OS, Katsifa K, Tselioti P, Foussas SG, Prekates AA. Incidence and predictors of new-onset atrial fibrillation in noncardiac intensive care unit patients. J Crit Care. 2014 Aug;29 — View Citation

Marik PE, Taeb AM. SIRS, qSOFA and new sepsis definition. J Thorac Dis. 2017 Apr;9(4):943-945. doi: 10.21037/jtd.2017.03.125. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Risk Factors of cardiac arrhythmias in septic patients in CU. any medical condition precipitate the occurrence of cardiac arrhythmia 3 week from admission in CU
Primary Fates of cardiac arrhythmia. what complications will precipitate the arrhythmia or the recovery achievement 1 month from the primary endpoint
Secondary The frequent type of arrhythmias. the most frequent type of cardiac arrhythmia 2 years from starting collaboration
Secondary Mortality rate due to new onset arrhythmia. the number of deaths from the enrolled patients 2 years from starting collaboration
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