The Relationship Between Renal Functions and Multi Drug Resistant Organisms

NCT04833231 | Completed

• 1 other identifier: omurilban1
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Glomerular Filtration Rate; Drug Resistance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya Numune Hospital: lead

Study Sites (1)

Konya Numune Hospital

Konya, 42060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Omur ILBAN, MD

  Konya Numune Hospital, Department of Intensive Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 6, 2021
• Study Start: August 1, 2019
• Primary Completion: January 15, 2021
• Study Completion: January 31, 2021
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

TU (1)