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

Cardiac Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06351956
• Other study ID #: Arrhythmias in Septic Patients
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

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