Critical IllnessNCT04763239
Prognostic Significance of Red Blood Cell
An observational study of Critical Illness, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Critical Illness
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Aug 2022
- 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 1 month to 12 years
- All sexes
- Child
Study population: All patients included in this study will be subjected to the following (as detailed in the attached patient's data sheet).
Who may be able to join
- All critically ill pediatric patients, 1 month to 12 years age, admitted to Pediatric intermediate \& Intensive Care Unit ( PICU ) in Sohag University Hospital.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Significance of Red Blood Cell Distribution Width (RDW) in Critically Ill Pediatric Patients at Sohag University Hospital
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.
Read the 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 .
- Conditions
- Critical Illness
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of hospital admission
in days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rezk atalla massoud, Sohag University
- Investigators
- shimaa mahmoud, Professor, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763239
- Sponsor's protocol ID
- Soh-Med-21-02-14
- Status last verified
- Aug 2022
- First submitted
- 15 Feb 2021
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
PubMed 15758012Jo YH, Kim K, Lee JH, Kang C, Kim T, Park HM, Kang KW, Kim J, Rhee JE. Red cell distribution width is a prognostic factor in severe sepsis and septic shock. Am J Emerg Med. 2013 Mar;31(3):545-8. doi: 10.1016/j.ajem.2012.10.017. Epub 2013 Feb 4.
PubMed 23380094
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Red Blood Cell Distribution Width (RDW) in Critically Ill Pediatric Patients at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT04763239
- Acronym / sponsor ID
- Soh-Med-21-02-14
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 21 Feb 2021 (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.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- All patients included in this study will be subjected to the following (as detailed in the attached patient's data sheet).
Key inclusion criteria (1 listed)
- All critically ill pediatric patients, 1 month to 12 years age, admitted to Pediatric intermediate \& Intensive Care Unit ( PICU ) in Sohag University Hospital.
Key exclusion criteria (2 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
duration of hospital admission
Time frame: 6 months
in days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Background: PubMed 15758012Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
- Background: PubMed 23380094Jo YH, Kim K, Lee JH, Kang C, Kim T, Park HM, Kang KW, Kim J, Rhee JE. Red cell distribution width is a prognostic factor in severe sepsis and septic shock. Am J Emerg Med. 2013 Mar;31(3):545-8. doi: 10.1016/j.ajem.2012.10.017. Epub 2013 Feb 4.
- Individual participant dataSharing planned: Undecided
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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.
shimaa mahmoud, Professor study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of hospital admission (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04763239, which also lists 2 linked publications.
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 29 Aug 2022.