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Use of Red Cell Distribution Width for Prediction of New-onset Atrial Fibrillation in Critically Ill Sepsis Patients

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ClinicalTrials.gov Identifier: NCT03523676
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Elsayed, Ain Shams University

Study Description
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Brief 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..

Condition or disease Intervention/treatment
Atrial Fibrillation New Onset Diagnostic Test: Red Cell Distribution Width

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
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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Red Cell Distribution Width to Predict New-onset Atrial Fibrillation in Critically Ill Sepsis Patients
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : March 10, 2018

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Group A
sepsis patients who did not develop atrial fibrillation during ICU stay
 Diagnostic Test: Red Cell Distribution Width
Group B
sepsis patients with newly developed atrial fibrillation during ICU stay
 Diagnostic Test: Red Cell Distribution Width


Outcome Measures
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Primary Outcome Measures :
  1. New-Onset atrial fibrillation , confirmed by electrocardiographical assessment [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523676


Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Diaaeldein Ibrahim, MD Ain Shams University
More Information
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Responsible Party: Ahmed Elsayed, Clinical researcher, Ain Shams University
ClinicalTrials.gov Identifier: NCT03523676    
Other Study ID Numbers: R33 /2018
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes