The Relationship Between Renal Functions and Multi Drug Resistant Organisms

NCT ID: NCT04833231

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 133 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-01-31

Brief 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 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.

Conditions

Chronic Kidney Disease; Glomerular Filtration Rate; Drug Resistance

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this 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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konya Numune Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Omur ILBAN

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omur ILBAN, MD

Role: PRINCIPAL_INVESTIGATOR

Konya Numune Hospital, Department of Intensive Care

Locations

Konya Numune Hospital

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

omurilban1

Identifier Type: -

Identifier Source: org_study_id