NCT04739748

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

January 28, 2021

Last Update Submit

February 4, 2021

Conditions

Keywords

Red cell distribution widthneutrophil-lymphocyte ratioIntensive care unitsRespiratory

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Respiratory ICU patient

patient in RICU that developed ventilator-associated pneumonia

Diagnostic Test: complete blood picture

Interventions

complete blood pictureDIAGNOSTIC_TEST

Measure the red blood cell distribution width (RDW), the neutrophil-lymphocyte ratio (NLR).

Respiratory ICU patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with the clinical suspicion of VAP in the Respiratory ICU were included in the study.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chest Department-faculty of medicine-Assuit university

Asyut, Egypt

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecture in Faculty of medicine,Assiut University

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 5, 2021

Study Start

April 6, 2018

Primary Completion

December 7, 2019

Study Completion

December 7, 2019

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations