Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04833231
Other study ID # omurilban1
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated NCT04043026 - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed NCT05318014 - Low-protein Formula Supplements in Chronic Kidney Disease N/A
Active, not recruiting NCT06071065 - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients N/A
Completed NCT02878317 - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting NCT06039254 - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function Phase 1
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Completed NCT02896309 - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity N/A
Withdrawn NCT02885545 - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial Phase 4
Completed NCT02756520 - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT02875886 - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease Phase 4
Completed NCT02836574 - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease Phase 2
Active, not recruiting NCT02483039 - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization N/A
Terminated NCT02543177 - Optimised Procedure in Patients With NSTEMI and CKD N/A
Completed NCT02369549 - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease Phase 3
Completed NCT02992548 - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease Phase 4
Recruiting NCT02205944 - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes N/A
Active, not recruiting NCT02231138 - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease Phase 4