NCT06351956

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Apr 2024

Typical duration for all trials

Status
not yet recruiting

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

Study Progress80%
Apr 2024Dec 2026

First Submitted

Initial submission to the registry

March 2, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

April 20, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

March 2, 2024

Last Update Submit

April 4, 2024

Conditions

Keywords

cardiac arrhythmiasepsiscritical care

Outcome Measures

Primary Outcomes (2)

  • 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

  • Fates of cardiac arrhythmia.

    what complications will precipitate the arrhythmia or the recovery achievement

    1 month from the primary endpoint

Secondary Outcomes (2)

  • The frequent type of arrhythmias.

    2 years from starting collaboration

  • Mortality rate due to new onset arrhythmia.

    2 years from starting collaboration

Eligibility Criteria

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

You may qualify if:

  • Adult patient of 18 years old and above of both gender admitted with manifestation of sepsis.

You may not qualify if:

  • Patients below 18 years old.
  • Pregnant females.
  • Patients with cardiac arrhythmia before admission in the critical unit.
  • Patients with previous cardiac surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Arrhythmias, CardiacSepsis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammation

Central Study Contacts

Dina Sameh, Bachelor's

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

March 2, 2024

First Posted

April 8, 2024

Study Start

April 20, 2024

Primary Completion

April 20, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 8, 2024

Record last verified: 2024-04