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Prognostic Significance of Red Blood Cell

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ClinicalTrials.gov Identifier: NCT04763239
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
rezk atalla massoud, Sohag University

Study Description
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Brief Summary:

Red blood cell (RBC) distribution width (RDW), calculated by dividing the standard deviation of RBC volume by the mean corpuscular volume and multiplied by 100, is routinely reported as part of the complete blood count (CBC) using automated flow cytometry. RDW has been traditionally used as additional information in the differential diagnosis of the cause of anemia.

RDW has been recently reported as a strong prognostic factor in several diseases of various organ systems, including the cardiovascular, respiratory, renal, neurologic, and gastrointestinal systems.It also showed significant associations with ventilator-free days, postoperative outcome, intensive care unit (ICU) discharge outcome, out-of-hospital outcome, and all-cause mortality in critically ill patients. However, most studies were conducted in adult patients. Only a few studies have investigated RDW in children, especially in the critically ill pediatric population.


Condition or disease
Critical Illness

Detailed Description:
The aim of this study is to know the prognostic significance of red blood cell distribution width ( RDW ) in critically ill pediatric patients as regard ; the duration of hospital & PICU admission ,the use of inotropic drugs and or mechanical ventilation (MV) and the outcome of the case .
Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prognostic Significance of Red Blood Cell Distribution Width (RDW) in Critically Ill Pediatric Patients at Sohag University Hospital
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. duration of hospital admission [ Time Frame: 6 months ]
    in days


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 12 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients included in this study will be subjected to the following (as detailed in the attached patient's data sheet).
Criteria

Inclusion Criteria:

  • All critically ill pediatric patients, 1 month to 12 years age, admitted to Pediatric intermediate & Intensive Care Unit ( PICU ) in Sohag University Hospital.

Exclusion Criteria:

  • - patients who received blood transfusion prior to admission in PICU
  • patients with incomplete data for pediatric risk of mortality (PRISM), pediatric sequential organ failure assessment (pSOFA), pediatric logistic organ dysfunction-2 (PELOD-2), and pediatric multiple organ dysfunction syndrome (pMODS) scores were excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763239


Contacts
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Contact: Rezk Atalla, Dr 01023077762 rezkatalla1987@gmail.com
Contact: Alzahraa Elsayed, Professor

Locations
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Egypt
Sohag faculty of medicine Recruiting
Sohag, Egypt
Sponsors and Collaborators
Sohag University
Investigators
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Study Director: shimaa mahmoud, Professor sohag university hospital
More Information
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Publications:

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Responsible Party: rezk atalla massoud, Principal Investigator, Sohag University
ClinicalTrials.gov Identifier: NCT04763239    
Other Study ID Numbers: Soh-Med-21-02-14
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes