NCT03523676

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..

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

May 2, 2018

Last Update Submit

May 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • New-Onset atrial fibrillation , confirmed by electrocardiographical assessment

    7 days

Study Arms (2)

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

Interventions

Group AGroup B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Erythrocyte Indices

Intervention Hierarchy (Ancestors)

Hematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Diaaeldein Ibrahim, MD

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical researcher

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 14, 2018

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

March 10, 2018

Last Updated

May 14, 2018

Record last verified: 2018-05