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

May 2, 2018 updated by: Ahmed Elsayed, Ain Shams University

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..

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

70

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
sepsis patients who did not develop atrial fibrillation during ICU stay
Group B
sepsis patients with newly developed atrial fibrillation during ICU stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
New-Onset atrial fibrillation , confirmed by electrocardiographical assessment
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Diaaeldein Ibrahim, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

March 10, 2018

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • R33 /2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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