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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04620941
Other study ID # 27/12/2019-19/XI
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date February 21, 2020
Est. completion date September 21, 2023

Study information

Verified date January 2022
Source Mugla Sitki Koçman University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections in the intensive care unit, affecting one third of patients requiring mechanical ventilation for a noninfectious reason. In the case of inflammation, iron retention increases in the reticuloendothelial system cells; hemoglobin (Hb) synthesis is reduced. It has been reported that the ratio of reticulocyte / hemoglobin (Ret-He) decreases in the early period in community-acquired pneumonia patients and may be a guide as a marker of inflammation. In addition, the neutrophil / lymphocyte ratio (NLR) is a parameter studied in the hemogram panel. It provides a clue to both the presence of infection and the focus of the infection. 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.


Recruitment information / eligibility

Status Suspended
Enrollment 35
Est. completion date September 21, 2023
Est. primary completion date July 21, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: -Patients who need mechanical ventilation for longer than 48 hours for a noninfectious reason in the intensive care unit Exclusion Criteria: - Pulmonary or extrapulmonary infection before mechanical ventilation, - severe immunosuppression, - bleeding in the gastrointestinal system, - using corticosteroids, - neoplastic disease history

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Mugla Sitki Kocman Universty Mugla Kötekli

Sponsors (1)

Lead Sponsor Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early inflammation markers for VAP To investigate the use of NLR and Ret-He value as early inflammation markers for VAP. 7 days
Secondary morbidity and mortality To compare the effects of Ret-He and NLR values on morbidity and mortality with other inflammation markers 7 days
See also
  Status Clinical Trial Phase
Recruiting NCT04926493 - Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Patients at Increased Risk for the Development of Ventilator-associated Pneumonia in the Intensive Care Unit
Terminated NCT01853982 - Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia Phase 3
Completed NCT01808092 - A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia Phase 3