The Relationship Between Renal Functions and Multi Drug Resistant Organisms

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Glomerular Filtration Rate; Drug Resistance

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 Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42060
    • Konya Numune Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The patients who were intubated endotracheally and received mechanical ventilation treatment for at least 48 hours in ICU.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months

Collaborators and Investigators

• Sponsor: Konya Numune Hospital
• Investigators: Principal Investigator: Omur ILBAN, MD, Konya Numune Hospital, Department of Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 3, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: omurilban1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No