- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04739748
Prognostic Biomarkers in Predicting Mortality in Respiratory Patients With Ventilator-Associated Pneumonia
February 4, 2021 updated by: Nermeen Aly Mahmoud Abdel Aleem, Assiut University
The aim of this study is to evaluate prognostic efficiency RDW and NLR for mortality prediction in respiratory patients with VAP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
136
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assuit, Egypt
- Chest Department-faculty of medicine-Assuit university
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients with the clinical suspicion of VAP in the Respiratory ICU were included in the study.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Respiratory ICU patient
patient in RICU that developed ventilator-associated pneumonia
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Measure the red blood cell distribution width (RDW), the neutrophil-lymphocyte ratio (NLR).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Mortality
Time Frame: 45 days
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The number of patients who not Survive after developing ventilator-associated pneumonia in their stay in the Respiratory Intensive Care Unit.
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45 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Chastre 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.
- Bello 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 6, 2018
Primary Completion (ACTUAL)
December 7, 2019
Study Completion (ACTUAL)
December 7, 2019
Study Registration Dates
First Submitted
January 28, 2021
First Submitted That Met QC Criteria
February 2, 2021
First Posted (ACTUAL)
February 5, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2021
Last Update Submitted That Met QC Criteria
February 4, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB17300520
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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