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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04739748
Other study ID # IRB17300520
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 6, 2018
Est. completion date December 7, 2019

Study information

Verified date February 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate prognostic efficiency RDW and NLR for mortality prediction in respiratory patients with VAP.


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.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date December 7, 2019
Est. primary completion date December 7, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
complete blood picture
Measure the red blood cell distribution width (RDW), the neutrophil-lymphocyte ratio (NLR).

Locations

Country Name City State
Egypt Chest Department-faculty of medicine-Assuit university Assuit

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Bello S, Fandos S, Lasierra AB, Mincholé 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 Me — View Citation

Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital Mortality The number of patients who not Survive after developing ventilator-associated pneumonia in their stay in the Respiratory Intensive Care Unit. 45 days
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