The Relationship Between Renal Functions and Multi Drug Resistant Organisms

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833231
• Other study ID #: omurilban1
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: March 2024
• Source: Konya Numune Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: January 31, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Drug Resistance
• Glomerular Filtration Rate
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Turkey	Konya Numune Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Numune Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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