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Lipid Kinetics of Patients With Pneumonia

Sponsor
Konya Numune Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04748432
Collaborator
(none)
131
Enrollment
1
Location
19.3
Actual Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    131 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Lipid Kinetics of Patients With Nonfermenting Gram-Negative Bacterial Ventilator-Associated Pneumonia
    Actual Study Start Date :
    May 25, 2019
    Actual Primary Completion Date :
    Dec 15, 2020
    Actual Study Completion Date :
    Dec 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Serum lipid metabolism [18 months]

      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

    Secondary Outcome Measures

    1. Clinical outcome [18 months]

      The secondary outcome were the 30-day mortality rate of the patients depending on the resistance profile of NFGNB

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Konya Numune Hospital Konya Turkey 42060

    Sponsors and Collaborators

    • Konya Numune Hospital

    Investigators

    • Principal Investigator: Omur ILBAN, MD, Konya Numune Hospital, Department of Intensive Care

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Omur ILBAN, Principal investigator, Konya Numune Hospital
    ClinicalTrials.gov Identifier:
    NCT04748432
    Other Study ID Numbers:
    • omurilban
    First Posted:
    Feb 10, 2021
    Last Update Posted:
    Feb 10, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pneumonia
    Cross Infection

    Study Results

    No Results Posted as of Feb 10, 2021