Atrial Fibrillation New OnsetNCT03523676
Use of Red Cell Distribution Width for Prediction of New-onset Atrial Fibrillation in Critically Ill Sepsis Patients
An observational study of Atrial Fibrillation New Onset, run by Ain Shams University.
Trial summary
Red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population.. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- Red Cell Distribution Width
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 10 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 70 patients of both sexes were enrolled in this study. They were admitted to the general ICU of Ain Shams University Hospitals with sepsis or septic shock
Who may be able to join
- For all patients According to Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) , adult patients with suspected infection are identified, having quickSOFA (qSOFA) score meeting ≥2 of the following criteria: respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mmHg or less
- Sepsis patients with newly developed Atrial fibrillation during ICU stay.
Who cannot join
- All patients with concomitant valvular disease, cardiomyopathy, cardiac dysrhythmias, previous cardiac surgery, secondary hypertension, hyperthyroidism, severe head injury, stroke, coma, acute coronary artery disease or underlying cardiac dysfunction[cardiac index (CI) <2.2 l/min/m 2 ], severe liver disease (Child-Pugh grade C), chronic renal failure were excluded from the study. In addition, pregnant patients were excluded.
About this study
Official title: Evaluation of Red Cell Distribution Width to Predict New-onset Atrial Fibrillation in Critically Ill Sepsis Patients
Red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population..
Read the detailed description
This study was done retrospectively on sepsis patients admitted to intensive care units. data will be retrieved from patient medical records. The primay end point will be occurrence of new-onset AF during ICU stay. The secondary outcomes will be 28-day mortality.
The presence of anisocytosis or RDW variations has been classicaly used as a test for iron deficiency anemia. Increasing evidence points to its potential as a predictor for various conditions such as heart failure , malignancy, ischemic heart disease and sepsis.
Study investigators will examine the relationship between RDW levels and incidence of atrial fibrillation in critically ill sepsis patients as well as 28-day mortality.
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- Red Cell Distribution Width
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Cell Distribution WidthDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Group A | sepsis patients who did not develop atrial fibrillation during ICU stay Receives: Diagnostic Test: Red Cell Distribution Width | |
| Group B | sepsis patients with newly developed atrial fibrillation during ICU stay Receives: Diagnostic Test: Red Cell Distribution Width |
What is being measured
The primary outcome is the main question the study is designed to answer.
New-Onset atrial fibrillation , confirmed by electrocardiographical assessment
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Jan 2017
- Primary completion1 Jan 2018
- Study completion10 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation New OnsetStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed, Ain Shams University
- Investigators
- Diaaeldein Ibrahim, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523676
- Sponsor's protocol ID
- R33 /2018
- Status last verified
- May 2018
- First submitted
- 2 May 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Red Cell Distribution Width to Predict New-onset Atrial Fibrillation in Critically Ill Sepsis Patients
- ClinicalTrials.gov ID
- NCT03523676
- Acronym / sponsor ID
- R33 /2018
- Conditions
- Atrial Fibrillation New Onset
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 10 Mar 2018 (actual)
- First posted
- 14 May 2018 (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.
Red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population..
Detailed description
This study was done retrospectively on sepsis patients admitted to intensive care units. data will be retrieved from patient medical records. The primay end point will be occurrence of new-onset AF during ICU stay. The secondary outcomes will be 28-day mortality.
The presence of anisocytosis or RDW variations has been classicaly used as a test for iron deficiency anemia. Increasing evidence points to its potential as a predictor for various conditions such as heart failure , malignancy, ischemic heart disease and sepsis.
Study investigators will examine the relationship between RDW levels and incidence of atrial fibrillation in critically ill sepsis patients as well as 28-day mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: Red Cell Distribution Widthsepsis patients who did not develop atrial fibrillation during ICU stay |
| Group B | – | Diagnostic Test: Red Cell Distribution Widthsepsis patients with newly developed atrial fibrillation during ICU stay |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 patients of both sexes were enrolled in this study. They were admitted to the general ICU of Ain Shams University Hospitals with sepsis or septic shock
Key inclusion criteria (2 listed)
- For all patients According to Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) , adult patients with suspected infection are identified, having quickSOFA (qSOFA) score meeting ≥2 of the following criteria: respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mmHg or less
- Sepsis patients with newly developed Atrial fibrillation during ICU stay.
Key exclusion criteria (1 listed)
- All patients with concomitant valvular disease, cardiomyopathy, cardiac dysrhythmias, previous cardiac surgery, secondary hypertension, hyperthyroidism, severe head injury, stroke, coma, acute coronary artery disease or underlying cardiac dysfunction[cardiac index (CI) <2.2 l/min/m 2 ], severe liver disease (Child-Pugh grade C), chronic renal failure were excluded from the study. In addition, pregnant patients were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Cell Distribution Width | Diagnostic test | Group A, Group B |
Primary outcome
New-Onset atrial fibrillation , confirmed by electrocardiographical assessment
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Diaaeldein Ibrahim, MD study director
Ain Shams University
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation New Onset, run by Ain Shams 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 14 May 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New-Onset atrial fibrillation , confirmed by electrocardiographical assessment (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2018.