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Completed

NCT Number: NCT04833231

The Relationship Between Renal Functions and Multi Drug Resistant Organisms

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Acute kidney injury
  • Renal replacement treatment (RRT)
  • Dialysis
  • Renal transplantation
  • Active tuberculosis
  • Malnutrition
  • 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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Konya Numune Hospital

Other Gov

Registry information

Official study title

The Relationship Between Renal Functions and Multi Drug Resistant Organisms in Patients With Ventilator Associated Pneumonia

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2021
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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