Clinical trial NCT06351956: New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes.
Official title: New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Arrhythmia
Keywords: cardiac arrhythmia
sepsis
critical care
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients aged from 18 years and above of both sexes (male and female) who are admitted in critical care unit in Assuit University Hospital and diagnosed by sepsis will be enrolled if matched the eligibility criteria

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Risk Factors of cardiac arrhythmias in septic patients in CU.
timeFrame: 3 week from admission in CU
measure: Fates of cardiac arrhythmia.
timeFrame: 1 month from the primary endpoint
Secondary outcomes:
measure: The frequent type of arrhythmias.
timeFrame: 2 years from starting collaboration
measure: Mortality rate due to new onset arrhythmia.
timeFrame: 2 years from starting collaboration
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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(4):697.e1-5. doi: 10.1016/j.jcrc.2014.03.029. Epub 2014 Apr 4.