Lipid Kinetics of Patients With Pneumonia

NCT04748432 | Completed

• 1 other identifier: omurilban
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

Nonfermenting Gram-Negative Bacilli (NFGNB) are aerobic, non-motile, non-lactose fermenting, oxidase-negative, catalase-positive coccobacilli that pose a serious threat to critically ill patients. Primarily Pseudomonas aeruginosa (PA) and Acinetobacter baumannii (AB), are NFGNB which are potential multi-drug resistant (MDR) pathogens that are related to ventilator-associated pneumonia (VAP). In Nonfermenting Gram-Negative Bacilli (NFGNB) infections, which are potential multi-drug resistant (MDR) pathogens, pathogenesis is determined not only by bacterial virulence factors but more importantly by the interaction between bacteria and the host immune system. Thanks to their direct immunomodulatory properties, lipoproteins and lipids bind and neutralise toxic bacterial substances. During the acute phase response and inflammation, HDL presents significant structural and functional changes. This study was planned to evaluate the relationship between the changes of the serum lipid metabolism and other inflammation markers with the antimicrobial resistance status and the results in NFGNB VAP patients. Also, we aimed to investigate whether there is a difference in the clinical characteristics of the patients depending on the resistance profile of NFGNB.

Conditions

Gram-negative Bacteria; Lipid Metabolism; Nosocomial Infections

Outcome Measures

Primary Outcomes (1)

• Serum lipid metabolism

  The relationship between the changes of the serum lipid metabolism including total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and triglycerides with the antimicrobial resistance status and the results in NFGNB VAP patients

  18 months

Secondary Outcomes (1)

• Clinical outcome

  18 months

Study Arms (3)

Multi-drug resistant group (MDR)

Patients with resistant NFGNB isolate as MDR group

Non-Multi-drug resistant group (Non-MDR)

Patients with sensitive NFGNB isolate as Non-MDR group

Control group (Control)

Patients without suspicion of VAP and other signs of nosocomial infection as the control 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:

• ICU Patients of 18 years of age and above, with clinical suspicion of VAP as defined in the American Thoracic Society (ATS) guidelines and a simplified version of Clinical Pulmonary Infection Score (CPIS)\> 6, with significant NFGNB growth in respiratory cultures and with no signs and symptoms of infection at the time of admission, were included in the study.

You may not qualify if:

• Patients with chronic inflammatory disease, hepatic dysfunction, active tuberculosis, malignancy, malnutrition, severe immunosuppression (i.e., neutropenia, HIV positive, organ transplant, having received immunosuppressants or used ≥ 20 mg/day prednisone for two or more weeks in the preceding three months), those that within 72 hours since being included in the study had any extrapulmonary infection other than VAP, as well as those whose respiratory cultures presented bacterial agents other than NFGNB and fungal agents were not included in the study.

Sponsors & Collaborators

• Konya Numune Hospital: lead

Study Sites (1)

Konya Numune Hospital

Konya, 42060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic 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: February 3, 2021
• First Posted: February 10, 2021
• Study Start: May 25, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 31, 2020
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

TU (1)