Prognostic Value of Complete Blood Count in Severe Infections

September 25, 2018 updated by: Doaa Heshmat, Assiut University

Prognostic Value of Complete Blood Count in Children Suffering of Severe Infections in Pediatric Care Unit

Sepsis is a leading cause of hospitalization in pediatric intensive care units, In the last decade, a series of initiatives were implemented that aim not only to improve the understanding of sepsis and the clarity of concepts related to this condition but also to reduce morbidity and mortality due to sepsis through earlier diagnosis and initiation of antibiotic therapy as well as through the provision of specific guidelines for the treatment of pediatric sepsis. Despite these measures and the lower mortality from sepsis in children compared to adult patients, the impact of sepsis in the pediatric population remains high.

Study Overview

Status

Unknown

Conditions

Detailed Description

According to the World Health Organization, sepsis remains a leading cause of death in infants and children in developed and developing countries.Some prognostic scoring systems with performance status, clinical symptoms, and biochemical parameters help to guide accurate prediction of the prognosis, such as the acute physiology and chronic health evaluation (APACHE), yet are considered too complex for general clinical use. Therefore, the prediction of clinical events with laboratory parameters, including complete blood cell count (CBC), has become an increased focus of research.

Accumulating evidence indicates that the CBC is an effective predictor of prognosis and mortality in many disease states, including hematological disease, neoplasms, and diseases of the circulatory system severe infections. Therefore, nonspecific changes in the CBC in critically ill patients could be considered a key prognostic factor in the evaluation of survival prediction in these patients .

According , it is possible that the CBC could be used as a predictor of survival in severe infections patients. The complete blood count (CBC) , a five-cell automated differential count and a reflex manual differential count (when required by protocol) and is one of the most frequently ordered admission laboratory tests.

In practice, it is a routine ingredient of all hospital admission orders - a complete blood count is done for our medical , surgical admissions and the same is true at most institutions . it is known that the white blood cell count do predict disease severity and mortality risk. For example, elevated WBC counts predict a worse prognosis in patients with severe infections in pediatric intensive care unit ,Further, this test provides direct management guidance in common circumstances, e.g., infection.

The CBC describes the number and morphology of over 40 different cells. Disagreement exists regarding the clinical significance of many of these observations. And only a few components of the manual differential, e.g., nucleated red blood cells and lymphocytes, have been quantitatively evaluated to determine their prognostic significance. But these two observations have not been examined to determine their independent contributions to mortality predictions when taken in conjunction with their accompanying CBC observations. .

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • patients will be classified into three groups according to the outcome(discharge, mortality and has morbidity sequel.)
  • Correlation between the outcome and blood culture will be done.
  • correlation between the out come AndCRPwill be done.
  • Then another correlation between the outcome and CBC will be done.
  • Comparison between the two previous correlations will be done to detect if CBC alone can predict the outcome of the patients.

Description

Inclusion Criteria:

  1. Age less than 18 years and > one month .
  2. patient presented with sepsis defined as suspected source of infection (we defined sepsis using predetermined international sepsis definitions as clinical syndrome with both infection and a systemic inflammatory response) .
  3. Abnormal leukocyte count >12×109 /cmm or<4 × 109/cmm or>10% immature form.
  4. patients presented with secondary organ dysfunction.

Exclusion Criteria:

  1. Age more than 18 years and age less than one month.
  2. patient with active bleeding.
  3. patient who had used anti platelet drugs .
  4. patient not diagnosed sepsis or septic shock.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prognosis of outcome in patients suffering from severe infections in PICU by using CBC .
Time Frame: one year
Complete blood count in children aged between one month and 18 years suffering of infections is enough as prognostic tool and predict the out come or not enough and more investigation will be required by correlation between CBC and the outcome of patients dead or discharge or morbid sequel.
one year

Collaborators and Investigators

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

Investigators

  • Principal Investigator: doaa heshmat, Assiut 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 (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

November 30, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Actual)

September 26, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Infection Systemic

Clinical Trials on role of CBC as prognostic tool in sepsis.

Subscribe