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

Atrial Fibrillation New Onset Clinical Trial

Official title:

Evaluation of Red Cell Distribution Width to Predict New-onset Atrial Fibrillation in Critically Ill Sepsis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523676
• Other study ID #: R33 /2018
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: March 10, 2018

Study information

• Verified date: May 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 10, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset
• Critical Illness

Intervention

Diagnostic Test:
• Red Cell Distribution Width

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New-Onset atrial fibrillation , confirmed by electrocardiographical assessment		7 days