NCT03685071

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

September 20, 2018

Last Update Submit

September 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • prognosis of outcome in patients suffering from severe infections in PICU by using CBC .

    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

Interventions

Our study will be conducted on children who admitted to PICU in Assuit University Hospital .CBC parameters as TLC , platelet count , and Hb will be evaluated at time of admission , another CBC will be done at 5th day and another one at day of discharge or last one before death. * patients will be classified into three groups according to the outcome(discharge, mortality and has morbidity sequel.) * correlation between the outcome and CBC will be done.

Eligibility Criteria

Age30 Days - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Age less than 18 years and \> one month .
  • 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) .
  • Abnormal leukocyte count \>12×109 /cmm or\<4 × 109/cmm or\>10% immature form.
  • patients presented with secondary organ dysfunction.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • doaa heshmat

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khaled Elsayh, proffessor

CONTACT

MOhamed Amir, ass.prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 26, 2018

Study Start

December 1, 2018

Primary Completion

November 30, 2019

Study Completion

June 1, 2020

Last Updated

September 26, 2018

Record last verified: 2018-09