Cardiac ArrhythmiaNCT06351956
New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes.
An observational study of Cardiac Arrhythmia, run by Assiut University.
Trial summary
New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrhythmia
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Adult patient of 18 years old and above of both gender admitted with manifestation of sepsis.
Who cannot join
- Patients below 18 years old.
- Pregnant females.
- Patients with cardiac arrhythmia before admission in the critical unit.
- Patients with previous cardiac surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes
Read the 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.
- Conditions
- Cardiac Arrhythmia
- Keywords
- cardiac arrhythmia, sepsis, critical care
- Medical subject headings
- Arrhythmias, Cardiac, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Factors of cardiac arrhythmias in septic patients in CU.
any medical condition precipitate the occurrence of cardiac arrhythmia
Measured: 3 week from admission in CU
Fates of cardiac arrhythmia.
what complications will precipitate the arrhythmia or the recovery achievement
Measured: 1 month from the primary endpoint
Secondary outcomes (2)
The frequent type of arrhythmias.
the most frequent type of cardiac arrhythmia
Measured: 2 years from starting collaboration
Mortality rate due to new onset arrhythmia.
the number of deaths from the enrolled patients
Measured: 2 years from starting collaboration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start20 Apr 2024 (estimated)
- Primary completion20 Apr 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Sameh Anwer, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351956
- Sponsor's protocol ID
- Arrhythmias in Septic Patients
- Status last verified
- Apr 2024
- First submitted
- 2 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28523143Makrygiannis 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.
PubMed 24814972
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes.
- ClinicalTrials.gov ID
- NCT06351956
- Acronym / sponsor ID
- Arrhythmias in Septic Patients
- Conditions
- Cardiac Arrhythmia
- Keywords
- cardiac arrhythmia, sepsis, critical care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Adult patient of 18 years old and above of both gender admitted with manifestation of sepsis.
Key exclusion criteria (4 listed)
- Patients below 18 years old.
- Pregnant females.
- Patients with cardiac arrhythmia before admission in the critical unit.
- Patients with previous cardiac surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk Factors of cardiac arrhythmias in septic patients in CU.
Time frame: 3 week from admission in CU
any medical condition precipitate the occurrence of cardiac arrhythmia
Fates of cardiac arrhythmia.
Time frame: 1 month from the primary endpoint
what complications will precipitate the arrhythmia or the recovery achievement
2 secondary outcomes
The frequent type of arrhythmias.
Time frame: 2 years from starting collaboration
Mortality rate due to new onset arrhythmia.
Time frame: 2 years from starting collaboration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Results publication: PubMed 28523143Marik 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.
- Results publication: PubMed 24814972Makrygiannis 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.
Related trials for Cardiac Arrhythmia
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Sameh, Bachelor's (01211947776, dinakoka96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Factors of cardiac arrhythmias in septic patients in CU. (time frame: 3 week from admission in CU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06351956, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.