Infection SystemicNCT03685071
Prognostic Value of Complete Blood Count in Severe Infections
An observational study of Infection Systemic, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 days to 18 years
- Conditions the study is for
- Infection Systemic
- What is being tested?
- role of CBC as prognostic tool in sepsis.
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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. .
- Conditions
- Infection Systemic
- Being tested
- role of CBC as prognostic tool in sepsis.
- Medical subject headings
- Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
role of CBC as prognostic tool in sepsis.Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Dec 2018 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection SystemicStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Heshmat, Assiut University
- Investigators
- doaa heshmat, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685071
- Sponsor's protocol ID
- PVCCSFSI
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Complete Blood Count in Children Suffering of Severe Infections in Pediatric Care Unit
- ClinicalTrials.gov ID
- NCT03685071
- Acronym / sponsor ID
- PVCCSFSI
- Conditions
- Infection Systemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| role of CBC as prognostic tool in sepsis.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. | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
doaa heshmat principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Infection Systemic, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khaled Elsayh, proffessor (01005484357, Khaledelsayh@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognosis of outcome in patients suffering from severe infections in PICU by using CBC . (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.