Oropharyngeal and intestinal microbiota: important factors in prevention or acquisition of nosocomial infections in patients admitted to the ICU after major elective surgery: an explorative pilot

Oropharyngeal and intestinal microbiota: important factors in prevention or acquisition of nosocomial infections in patients admitted to the ICU after major elective surgery: an explorative pilot - Role of microbiota in nosocomial infections

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40960

Enrollment

100

Registered

2014-09-05

Start date

2015-04-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection prevention

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients; >= 18 years of age Elective cardiothoracic surgery Screening pre-operatively by anaesthesiologist in policlinic in our center Admitted to ICU post-operatively - Able to give informed consent by themselves

Exclusion criteria

Exclusion criteria: Minor;

Design outcomes

Primary

Measure	Time frame
The objective of this observational pilot is the evaluation of incidence of HSMO- and HRMO-carriage, evaluation of oral and gut flora before, during and after hospitalization and evaluation of health status related to an ecological niche of these micro-organisms (oral cavity). Therefore, cultures taken by study protocol will be recorded, along with surveillance cultures taken by standard protocol and whole microbiome analysis. Oral health will be assessed using a standardized scale (Dutch Periodontal Screening Index -DPSI- Addendum I and Decayed Missing Filled Teeth Index (DMFT). Also, Post-Operative Wound Infections (POWIs), including mediastinitis and bacteremias will be recorded, as well as causative micro-organism(s) and time to diagnosis of infection from day of hospitalization. Additional outcome measures will be: Length of Stay (LOS) in hospital and ICU, duration of mechanical ventilation, duration of central line(s) in situ, antibiotic use from time of hospitalization until 8 weeks after admission, re-admission(s) to the ICU and indication for re-admission, re-exploration(s) and indication for re-exploration, quality of life (QOL) using a standardized scale before surgery and on post-discharge follow-up, and mortality until one year after inclusion. Further, the study log will contain anonymous demographic and clinical data of study subjects recorded on inclusion and during the study period. Associations between SAO (including mortality, bacteremia, POWI, longer (>= 4 days of stay in ICU and/ or mechanical ventilation) with baseline characteristics such as HRMO-carriage, oral health will be studied, as well as SAO in association with QOL. Incidence of colonization with specific micro-organisms such as Methicillin-susceptible and resistant S.aureus, Vancomycin-Resistant Enterococci (VRE), Gram-negatives, including HRMOs will be studied in association with baseline characteristics such as oral health, age. Duration of HRMO-carriage w	—

Measure

Time frame

The objective of this observational pilot is the evaluation of incidence of HSMO- and HRMO-carriage, evaluation of oral and gut flora before, during and after hospitalization and evaluation of health status related to an ecological niche of these micro-organisms (oral cavity). Therefore, cultures taken by study protocol will be recorded, along with surveillance cultures taken by standard protocol and whole microbiome analysis. Oral health will be assessed using a standardized scale (Dutch Periodontal Screening Index -DPSI- Addendum I and Decayed Missing Filled Teeth Index (DMFT). Also, Post-Operative Wound Infections (POWIs), including mediastinitis and bacteremias will be recorded, as well as causative micro-organism(s) and time to diagnosis of infection from day of hospitalization. Additional outcome measures will be: Length of Stay (LOS) in hospital and ICU, duration of mechanical ventilation, duration of central line(s) in situ, antibiotic use from time of hospitalization until 8 weeks after admission, re-admission(s) to the ICU and indication for re-admission, re-exploration(s) and indication for re-exploration, quality of life (QOL) using a standardized scale before surgery and on post-discharge follow-up, and mortality until one year after inclusion. Further, the study log will contain anonymous demographic and clinical data of study subjects recorded on inclusion and during the study period. Associations between SAO (including mortality, bacteremia, POWI, longer (>= 4 days of stay in ICU and/ or mechanical ventilation) with baseline characteristics such as HRMO-carriage, oral health will be studied, as well as SAO in association with QOL. Incidence of colonization with specific micro-organisms such as Methicillin-susceptible and resistant S.aureus, Vancomycin-Resistant Enterococci (VRE), Gram-negatives, including HRMOs will be studied in association with baseline characteristics such as oral health, age. Duration of HRMO-carriage w

—

Secondary

Measure	Time frame
Zie hierboven, Primary study parameters/outcome of the study	—

Countries

Netherlands

Outcome results