Chronic Kidney DiseaseNCT04833231
The Relationship Between Renal Functions and Multi Drug Resistant Organisms
An observational study of Chronic Kidney Disease and Glomerular Filtration Rate, run by Konya Numune Hospital at 1 site in Turkey (Türkiye).
Trial summary
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection in patients receiving invasive mechanical ventilation (MV). Antibiotic resistance poses an increasing threat due to the rise of infections caused by multidrug-resistant organisms (MDROs).Despite the increase in the frequency of MDRO… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Disease, Glomerular Filtration Rate, Drug Resistance
- How many people
- 133 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 31 Jan 2021
- How long will I take part?
- 18 Months
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who were intubated endotracheally and received mechanical ventilation treatment for at least 48 hours in ICU.
Who may be able to join
- Patients of 18 years of age and above
- A clinical suspicion of VAP as defined in the American Thoracic Society (ATS) guidelines
- A Clinical Pulmonary Infection Score (CPIS) > 6
- No signs and symptoms of infection at the time of admission to the ICU
Who cannot join
- Acute kidney injury
- Renal replacement treatment (RRT)
- Dialysis
- Renal transplantation
- Active tuberculosis
- Malnutrition
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- Immunosuppression (neutropenia, HIV positivity, transplantation, prednisone treatment of ≥20 mg/day, etc.)
- Any extrapulmonary infection other than VAP at the time of being included in the study
- Respiratory cultures presented fungal agents
- Normal flora
- No growth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Renal Functions and Multi Drug Resistant Organisms in Patients With Ventilator Associated Pneumonia
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection in patients receiving invasive mechanical ventilation (MV). Antibiotic resistance poses an increasing threat due to the rise of infections caused by multidrug-resistant organisms (MDROs).Despite the increase in the frequency of MDRO colonisation and infection in dialysis patients, it is not known enough whether the risk of multi-drug resistant (MDR) pneumonia increases in mild-to-severe chronic kidney disease (CKD) (eGFR <60 mL/min/1.73 m2) patients not receiving dialysis. Therefore, in our study, the investigators aimed to evaluate the relationship between renal functions and MDR VAP risk and the specific microbial pattern.
Read the detailed description
This prospective observational study was performed on adult patients intubated and receiving MV for at least 48 hours in the 42-bed surgical and medical Intensive Care Unit. The study was conducted between August 2019 and January 2021 and approved by the Ethics Committee of Necmettin Erbakan University Medical School. Informed consents were obtained from patients participating in the study or from their relatives. The characteristics of patients with MDRO infection associated with different eGFR categories in VAP patients were recorded.
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High eGFR group (eGFR ≥60 mL/ min/1.73 m2) | Patients with estimated glomerular filtration rate (eGFR) ≥60 mL/ min/1.73 m2 as high eGFR group | |
| Low eGFR group (eGFR <60 mL/min/1.73 m2) | Patients with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 as low eGFR group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-drug resistant (MDR) pneumonia
The presence of an infection with a resistant pathogen in patients with impaired renal function (eGFR <60 mL/min/1.73 m2) served as our primary outcome measure
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Aug 2019
- Primary completion15 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Konya Numune Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Omur ILBAN, Konya Numune Hospital
- Investigators
- Omur ILBAN, MD, Principal investigator, Konya Numune Hospital, Department of Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833231
- Sponsor's protocol ID
- omurilban1
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Renal Functions and Multi Drug Resistant Organisms in Patients With Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT04833231
- Acronym / sponsor ID
- omurilban1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Konya Numune HospitalOther government
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 6 Apr 2021 (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.
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection in patients receiving invasive mechanical ventilation (MV). Antibiotic resistance poses an increasing threat due to the rise of infections caused by multidrug-resistant organisms (MDROs).Despite the increase in the frequency of MDRO colonisation and infection in dialysis patients, it is not known enough whether the risk of multi-drug resistant (MDR) pneumonia increases in mild-to-severe chronic kidney disease (CKD) (eGFR <60 mL/min/1.73 m2) patients not receiving dialysis. Therefore, in our study, the investigators aimed to evaluate the relationship between renal functions and MDR VAP risk and the specific microbial pattern.
Detailed description
This prospective observational study was performed on adult patients intubated and receiving MV for at least 48 hours in the 42-bed surgical and medical Intensive Care Unit. The study was conducted between August 2019 and January 2021 and approved by the Ethics Committee of Necmettin Erbakan University Medical School. Informed consents were obtained from patients participating in the study or from their relatives. The characteristics of patients with MDRO infection associated with different eGFR categories in VAP patients were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High eGFR group (eGFR ≥60 mL/ min/1.73 m2) | – | –Patients with estimated glomerular filtration rate (eGFR) ≥60 mL/ min/1.73 m2 as high eGFR group |
| Low eGFR group (eGFR <60 mL/min/1.73 m2) | – | –Patients with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 as low eGFR group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who were intubated endotracheally and received mechanical ventilation treatment for at least 48 hours in ICU.
Key inclusion criteria (4 listed)
- Patients of 18 years of age and above
- A clinical suspicion of VAP as defined in the American Thoracic Society (ATS) guidelines
- A Clinical Pulmonary Infection Score (CPIS) > 6
- No signs and symptoms of infection at the time of admission to the ICU
Key exclusion criteria (11 listed)
- Acute kidney injury
- Renal replacement treatment (RRT)
- Dialysis
- Renal transplantation
- Active tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multi-drug resistant (MDR) pneumonia
Time frame: 18 months
The presence of an infection with a resistant pathogen in patients with impaired renal function (eGFR <60 mL/min/1.73 m2) served as our primary outcome measure
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 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Omur ILBAN, MD principal investigator
Konya Numune Hospital, Department of Intensive Care
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 Chronic Kidney Disease and Glomerular Filtration Rate, run by Konya Numune Hospital 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 4 inclusion and 11 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 12 Mar 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?
Multi-drug resistant (MDR) pneumonia (time frame: 18 months). 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 12 Mar 2024.