Ventilator Associated PneumoniaNCT04739748
Prognostic Biomarkers in Predicting Mortality in Respiratory Patients With Ventilator-Associated Pneumonia
An observational study of Ventilator Associated Pneumonia, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate prognostic efficiency RDW and NLR for mortality prediction in respiratory patients with VAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- complete blood picture
- How many people
- 136 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Apr 2018to 7 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with the clinical suspicion of VAP in the Respiratory ICU were included in the study.
Who may be able to join
- Respiratory failure needs mechanical ventilator support > 48 hrs. VAP was defined as an acute lower respiratory tract infection in mechanically ventilated patient > 48 hrs with a new or progressing infiltrate on chest radiograph and who met at least two of the following clinical criteria: body temperature >38°C or <36°C with no other recognized cause, white blood cell count >10,000 /mm3 or <5000 /mm3, or a macroscopically purulent tracheal aspirate
- Only the first VAP episode was included
Who cannot join
- Neutropenia (< 500 cells/ml) before the development of VAP.
- Conditions are known to influence total and differential WBC counts such as chronic inflammatory conditions, hematologic disorders, history of chemotherapy, or radiotherapy within 4 weeks before enrollment.
- Conditions are known to affect RDW as anemia due to nutritional deficiency (ie, iron, vitamin B12, and folic acid).
- Patients with HIV/AIDS
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate prognostic efficiency RDW and NLR for mortality prediction in respiratory patients with VAP.
Read the detailed description
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection. VAP continues to be a leading cause of morbidity and mortality in the nosocomial setting. Red cell distribution width (RDW) and neutrophil-lymphocyte ratio (NLR) are prognostic factors to mortality in different diseases.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- complete blood picture
- Keywords
- Red cell distribution width, neutrophil-lymphocyte ratio, Intensive care units, Respiratory
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete blood pictureDiagnostic test
Measure the red blood cell distribution width (RDW), the neutrophil-lymphocyte ratio (NLR).
| Study group | Role | What they receive |
|---|---|---|
| Respiratory ICU patient | patient in RICU that developed ventilator-associated pneumonia Receives: Diagnostic Test: complete blood picture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Mortality
The number of patients who not Survive after developing ventilator-associated pneumonia in their stay in the Respiratory Intensive Care Unit.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start6 Apr 2018
- Primary completion7 Dec 2019
- Study completion7 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen Aly Mahmoud Abdel Aleem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739748
- Sponsor's protocol ID
- IRB17300520
- Status last verified
- Feb 2021
- First submitted
- 28 Jan 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang KT, Tseng CC, Fang WF, Lin MC. An early predictor of the outcome of patients with ventilator-associated pneumonia. Chang Gung Med J. 2010 May-Jun;33(3):274-82.
PubMed 20584505Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.
PubMed 11934711Bello S, Fandos S, Lasierra AB, Minchole E, Panadero C, Simon AL, Gavin O, De Pablo F, Menendez R, Torres A. Red blood cell distribution width [RDW] and long-term mortality after community-acquired pneumonia. A comparison with proadrenomedullin. Respir Med. 2015 Sep;109(9):1193-206. doi: 10.1016/j.rmed.2015.07.003. Epub 2015 Jul 14.
PubMed 26205553
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Biomarkers in Predicting Mortality in Respiratory Patients With Ventilator-Associated Pneumonia
- ClinicalTrials.gov ID
- NCT04739748
- Acronym / sponsor ID
- IRB17300520
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Red cell distribution width, neutrophil-lymphocyte ratio, Intensive care units, Respiratory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 7 Dec 2019 (actual)
- Study completion
- 7 Dec 2019 (actual)
- First posted
- 5 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.
The aim of this study is to evaluate prognostic efficiency RDW and NLR for mortality prediction in respiratory patients with VAP.
Detailed description
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection. VAP continues to be a leading cause of morbidity and mortality in the nosocomial setting. Red cell distribution width (RDW) and neutrophil-lymphocyte ratio (NLR) are prognostic factors to mortality in different diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory ICU patient | – | Diagnostic Test: complete blood picturepatient in RICU that developed ventilator-associated pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with the clinical suspicion of VAP in the Respiratory ICU were included in the study.
Key inclusion criteria (2 listed)
- Respiratory failure needs mechanical ventilator support > 48 hrs. VAP was defined as an acute lower respiratory tract infection in mechanically ventilated patient > 48 hrs with a new or progressing infiltrate on chest radiograph and who met at least two of the following clinical criteria: body temperature >38°C or <36°C with no other recognized cause, white blood cell count >10,000 /mm3 or <5000 /mm3, or a macroscopically purulent tracheal aspirate
- Only the first VAP episode was included
Key exclusion criteria (4 listed)
- Neutropenia (< 500 cells/ml) before the development of VAP.
- Conditions are known to influence total and differential WBC counts such as chronic inflammatory conditions, hematologic disorders, history of chemotherapy, or radiotherapy within 4 weeks before enrollment.
- Conditions are known to affect RDW as anemia due to nutritional deficiency (ie, iron, vitamin B12, and folic acid).
- Patients with HIV/AIDS
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 |
|---|---|---|
| complete blood pictureMeasure the red blood cell distribution width (RDW), the neutrophil-lymphocyte ratio (NLR). | Diagnostic test | Respiratory ICU patient |
Primary outcome
Hospital Mortality
Time frame: 45 days
The number of patients who not Survive after developing ventilator-associated pneumonia in their stay in the Respiratory Intensive Care Unit.
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 8 Feb 2021.
- Results publication: PubMed 20584505Huang KT, Tseng CC, Fang WF, Lin MC. An early predictor of the outcome of patients with ventilator-associated pneumonia. Chang Gung Med J. 2010 May-Jun;33(3):274-82.
- Results publication: PubMed 11934711Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.
- Results publication: PubMed 26205553Bello S, Fandos S, Lasierra AB, Minchole E, Panadero C, Simon AL, Gavin O, De Pablo F, Menendez R, Torres A. Red blood cell distribution width [RDW] and long-term mortality after community-acquired pneumonia. A comparison with proadrenomedullin. Respir Med. 2015 Sep;109(9):1193-206. doi: 10.1016/j.rmed.2015.07.003. Epub 2015 Jul 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ventilator Associated Pneumonia, run by Assiut 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 2 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: finished, as of the sponsor's last update on 8 Feb 2021. 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?
Hospital Mortality (time frame: 45 days). 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 NCT04739748, which also lists 3 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 8 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.