NCT04620941

Brief Summary

In this study, the utility of changes in the ratio of Ret-He and NLR as an early inflammation marker for VAP will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

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

First Submitted

Initial submission to the registry

November 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 21, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

1.6 years

First QC Date

November 3, 2020

Last Update Submit

November 4, 2024

Conditions

Keywords

Ventilator-associated pneumoniareticulocyte/hemoglobin rationeutrophil/lymphocyte ratio

Outcome Measures

Primary Outcomes (1)

  • Early inflammation markers for VAP

    To investigate the use of NLR and Ret-He value as early inflammation markers for VAP.

    7 days

Secondary Outcomes (1)

  • morbidity and mortality

    7 days

Study Arms (1)

ventilator-associated pneumonia

Ret-He values will be studied on the day (1st day), 4th and 7th days of VID diagnosis in patients receiving mechanical ventilation support in the intensive care unit. The hemogram, CRP, and NLR values that are routinely studied in the intensive care unit will be recorded. In addition, in case of infection, the routinely studied procalcitonin value will also be recorded. The patient's age, gender, APACHE II, SOFA scores will be recorded; respiratory system examination, fever, the mental status evaluation will be done daily.

Diagnostic Test: reticulocyte/hemoglobin (Ret-He) ratio

Interventions

Ret-He values will be studied on the day (1st day), 4th and 7th days of the diagnosis of ventilator-associated pneumonia in patients hospitalized in the intensive care unit.

ventilator-associated pneumonia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who need mechanical ventilation for longer than 48 hours for a noninfectious reason in the intensive care unit

You may qualify if:

  • Patients who need mechanical ventilation for longer than 48 hours for a noninfectious reason in the intensive care unit

You may not qualify if:

  • Pulmonary or extrapulmonary infection before mechanical ventilation,
  • severe immunosuppression,
  • bleeding in the gastrointestinal system,
  • using corticosteroids,
  • neoplastic disease history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sitki Kocman Universty

Muğla, Kötekli, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Reticulocyte Count

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Erythrocyte CountBlood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • turhan togan

    Mugla Sitki Kocman Universty Department of Infection Disease

    STUDY CHAIR
  • Canan Gursoy

    Mugla Sitki Kocma University Department of Intensive Care

    STUDY CHAIR
  • Semra Demirbilek

    Mugla Sitki Kocman Universty Department of Anesthesia

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Muğla Sıtkı Koçman University Department of Anesthesiology Specialist

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 9, 2020

Study Start

February 21, 2022

Primary Completion

September 21, 2023

Study Completion

December 21, 2023

Last Updated

November 6, 2024

Record last verified: 2024-11

Locations