Lipid Kinetics of Patients With Pneumonia

Lipid Kinetics of Patients With Nonfermenting Gram-Negative Bacterial Ventilator-Associated Pneumonia

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.

Study Overview

• Status: Completed
• Conditions: Lipid Metabolism; Nosocomial Infections; Gram-negative Bacteria

Detailed Description

This prospective study was performed in adult intensive care unit (ICU) patients. They were intubated endotracheally and received mechanical ventilation (MV) treatment for at least 48 hours in Konya Numune Hospital ICU, which has 42 surgery and medicine beds. The study was conducted between May 2019 and December 2020 and approved by the Ethics Committee of Necmettin Erbakan University Medical School. Informed consents were obtained from the patients who participated in the study or from their relatives. The characteristics of the patients and the sequential changes of the inflammatory response including the lipid profile were recorded.

• Study Type: Observational
• Enrollment (Actual): 131

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:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome	The secondary outcome were the 30-day mortality rate of the patients depending on the resistance profile of NFGNB	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): May 25, 2019
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (Actual): February 10, 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; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Iatrogenic Disease; Pneumonia; Cross Infection
• Other Study ID Numbers: omurilban

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