The objective of this observational pilot is the evaluation of incidence of HSMO- and HRMO-carriage, evaluation of oral and gut microbiota before, during and after hospitalization and evaluation of health status related to an ecological niche of…
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- Hepatobiliary neoplasms malignant and unspecified
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Research involving
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Outcome measures
Primary outcome
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 will be evaluated.
Secondary outcome
Zie hierboven, Primary study parameters/outcome of the study
Background summary
Colonization with bacteria and associated prevention or acquisition of
nosocomial infections are important issues in critical care patients after
major elective surgery. Health-care associated infections lead to higher
antibiotic use inducing more antimicrobial resistance, higher mortality, longer
length of stay and greater costs. A rise in infections with Highly Resistant
Micro-Organisms (HRMOs) is currently seen. This rise is of relevance, because
infections with HRMOs are associated with higher mortality, longer length of
stay and higher costs compared with infections with Highly Susceptible
Micro-Organisms (HSMOs). Also, cross-contamination with HRMOs can occur when
adherence to infection control measures are neglected. Infections with HRMOs
are typically harder to treat, where resistance to first line antibiotics urges
the use of *rescue*- or second line antibiotics with little hope of new
effective alternatives in the near future. Although colonization with a HRMO in
critical care patients is often acquired on the Intensive Care Unit (ICU), a
large part of HRMOs found during surveillance in the ICU is imported rather
than acquired; also: own study results; submitted for publication; Addendum
II). This colonization could have occurred during stay on a general ward, in a
nursing facility, or in the community; in the latter situation the contribution
of antimicrobial resistance in intensive livestock farming seems to be on the
rise.
Besides colonization with HRMOs, suboptimal oral health poses a risk factor for
developing post-operative infections. Currently, assessment of oral health is
not routinely included in preoperative screening of patients scheduled for
cardiothoracic surgery.
Measures to prevent nosocomial infections and spread of HRMOs implemented in
daily practice in our ICU include contact isolation of those known to harbour
HRMO-colonization, use of a Ventilator-Associated Pneumonia (VAP)-prevention
*bundle* including standard oral care three times daily, and use of selective
decontamination of the digestive tract (SDD). Additionally, in those
cardiosurgery patients who are nasal carriers of Staphylococcus aureus
(S.aureus), decolonization of nasal and extranasal sites of S.aureus with
mupirocin nasal ointment and chlorhexidine soap is pursued in order to reduce
the risk of surgical-site infections with S.aureus.
SDD or selective oropharyngeal decontamination (SOD) is widely implemented on
Dutch ICUs. The use of SDD or SOD has shown to significantly reduce mortality
at day 28 and is associated with significantly less bacteremias and
colonization with HRMOs as compared with standard care. Although currently
restricted to the ICU and the hemato-oncology population, employment of SDD
perioperatively in elective gastrointestinal surgery patients has shown to
reduce anastomotic leakage and postoperative infectious complications. Benefits
notwithstanding, SDD does significantly alter the composition of intestinal
microbiota; clinical consequences of this effect are currently unknown.
Presently, surveillance screening in order to detect HRMOs will only occur on
ICU-admission or in the occasion of outbreaks; only then appropriate measures
will be taken to optimize antibiotic therapy and prevent cross-transmission.
In other words: at present, we deploy a reactive, instead of preventive
strategy.
Hypothesis:
Recognition of colonization with HSMOs and HRMOs at an earlier stage and
subsequent use of better preventive measures such as contact isolation,
eradication and antibiotic stewardship may help patient outcomes and may as
well be cost-effective. Also, optimization of oral health perioperatively could
reduce the risk of nosocomial infections, notably VAP. Finally, evaluation of
colonization with pathogenic micro-organisms and of the oral cavity and gut
microbiota - the constellation of microbes- in general before, during and after
hospitalization can help us to elucidate the effect of hospitalization,
including ICU stay, on the patient*s microbiota and the clinical effect of
alterations in this microbiota during the clinical course.
Study objective
The objective of this observational pilot is the evaluation of incidence of
HSMO- and HRMO-carriage, evaluation of oral and gut microbiota before, during
and after hospitalization and evaluation of health status related to an
ecological niche of these micro-organisms (oral cavity). The results of this
preliminary study should eventually lead to interventional studies resulting in
improvement in quality and efficacy of care and to improvement in quality of
life for critical care patients.
Our hypothesis generates several study questions:
-What is the incidence of colonization with HSMOs, HRMOs, S.aureus, and yeasts
in elective cardiothoracic surgery patients before, during, and after
hospitalization, including ICU stay?
-What is the composition of oral and faecal microbiota and how does this
composition change during the care process including stay in an ICU and a
general ward and all its relevant interventions during this stay, such as SDD?
-What is the status of oral health in this population?
-What is the relationship between HSMO- and HRMO-carriage, oral health and
socio-economic status?
-What is the relationship between HSMO- and HRMO-carriage, oral health, oral
and faecal microbiota and serious adverse outcomes (SAOs) such as
ICU-mortality, occurrence of Post-Operative Wound Infections (POWIs), longer (>=
4 days) length of stay in ICU, and longer (>= 4 days) length of mechanical
ventilation?
-What is the relationship between abovementioned SAOs and Quality of Life (QOL)?
-What is the duration of acquired HRMO-carriage?
Study design
Prospective, observational, single center cohort study.
Study burden and risks
Participation in this study will bring the individual participating patient in
this pilot study benefit nor harm. The collection of cultures from various body
sites and from faeces, the examination of the oral cavity and the completion of
a questionnaire regarding general health, demographics and life style are all
considered a minor burden.
No risk is anticipated as in this observational study no intervention as such
is done besides mentioned taking of cultures, assessment of oral health and
completion of a questionnaire.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
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
Minor; < 18 years of age
Unable to give informed consent
For periodontal cultures: patients who are edentate; in edentate patients, a culture of the plaque of the tongue will be obtained
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49237.042.14 |