Ventilator-associated Pneumonia (VAP)NCT04620941
Use of Reticulocyte Ratio and Neutrophil / Lymphocyte Ratio in the Diagnosis of Ventilator-associated Pneumonia
An observational study of Ventilator-associated Pneumonia (VAP), run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ventilator-associated Pneumonia (VAP)
- What is being tested?
- reticulocyte/hemoglobin (Ret-He) ratio
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Feb 2022to 21 Dec 2023
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients who need mechanical ventilation for longer than 48 hours for a noninfectious reason in the intensive care unit
Who may be able to join
- -Patients who need mechanical ventilation for longer than 48 hours for a noninfectious reason in the intensive care unit
Who cannot join
- Pulmonary or extrapulmonary infection before mechanical ventilation,
- severe immunosuppression,
- bleeding in the gastrointestinal system,
- using corticosteroids,
- neoplastic disease history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sitki Kocman Universty
Muğla, Kötekli, 48000
About this study
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.
Read the detailed 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.
- Conditions
- Ventilator-associated Pneumonia (VAP)
- Being tested
- reticulocyte/hemoglobin (Ret-He) ratio
- Keywords
- Ventilator-associated pneumonia, reticulocyte/hemoglobin ratio, neutrophil/lymphocyte ratio
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reticulocyte/hemoglobin (Ret-He) ratioDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: reticulocyte/hemoglobin (Ret-He) ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early inflammation markers for VAP
To investigate the use of NLR and Ret-He value as early inflammation markers for VAP.
Measured: 7 days
Secondary outcomes (1)
morbidity and mortality
To compare the effects of Ret-He and NLR values on morbidity and mortality with other inflammation markers
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start21 Feb 2022
- Primary completion21 Sep 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-associated Pneumonia (VAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem Yaşar, Muğla Sıtkı Koçman University
- Investigators
- turhan togan, Study chair, Mugla Sitki Kocman Universty Department of Infection DiseaseCanan Gursoy, Study chair, Mugla Sitki Kocma University Department of Intensive CareSemra Demirbilek, Study chair, Mugla Sitki Kocman Universty Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620941
- Sponsor's protocol ID
- 27/12/2019-19/XI
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2020
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Reticulocyte Ratio and Neutrophil / Lymphocyte Ratio in the Diagnosis of Ventilator-associated Pneumonia
- ClinicalTrials.gov ID
- NCT04620941
- Acronym / sponsor ID
- 27/12/2019-19/XI
- Conditions
- Ventilator-associated Pneumonia (VAP)
- Keywords
- Ventilator-associated pneumonia, reticulocyte/hemoglobin ratio, neutrophil/lymphocyte ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilator-associated pneumonia | – | Diagnostic Test: reticulocyte/hemoglobin (Ret-He) ratioRet-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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who need mechanical ventilation for longer than 48 hours for a noninfectious reason in the intensive care unit
Key inclusion criteria (1 listed)
- -Patients who need mechanical ventilation for longer than 48 hours for a noninfectious reason in the intensive care unit
Key exclusion criteria (5 listed)
- Pulmonary or extrapulmonary infection before mechanical ventilation,
- severe immunosuppression,
- bleeding in the gastrointestinal system,
- using corticosteroids,
- neoplastic disease history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reticulocyte/hemoglobin (Ret-He) ratioRet-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. | Diagnostic test | ventilator-associated pneumonia |
Primary outcome
Early inflammation markers for VAP
Time frame: 7 days
To investigate the use of NLR and Ret-He value as early inflammation markers for VAP.
1 secondary outcome
morbidity and mortality
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
Related trials for Ventilator-associated Pneumonia (VAP)
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Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
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Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
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Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
Ventilator Associated Pneumonia ( VAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
turhan togan study chair
Mugla Sitki Kocman Universty Department of Infection Disease
Canan Gursoy study chair
Mugla Sitki Kocma University Department of Intensive Care
Semra Demirbilek study chair
Mugla Sitki Kocman Universty Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-associated Pneumonia (VAP), run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early inflammation markers for VAP (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.