The primary objective is to investigate whether polytrauma patients (Injury Severity Score [ISS] >= 16) admitted to the ICU who have or develop malnutrition have a higher complication rate than patients who are and remain well-nourished.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Ernstig ongevalsletsel (polytrauma)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome in this study is the complication rate.
Secondary outcome
Other study parameters include pre-existent and in-hospital malnutrition,
hospital length of stay (HOS-LOS), intensive care length of stay (ICU-LOS),
ventilator-free days, surgery, discharge disposition, readmission,
calorie/protein deficit and biomarkers, and functional outcomes (Glasgow
Outcome Scale Extended and EQ-5D).
Background summary
Severely injured patients (polytrauma patients) are at risk of considerable
harm from malnutrition due to disease-related malnutrition with inflammation.
Recognition of sub-optimally nourished polytrauma patients and assessment of
their nutritional needs is crucial in order to improve their clinical outcomes.
Even though this is acknowledged, there is little knowledge of (the risk of)
malnutrition and its consequences in the polytrauma patient population.
Therefore the goal of our study is to investigate the prevalence of both
pre-existent and in-hospital developed malnutrition in polytrauma patients
admitted to the intensive care unit (ICU), to assess the association between
malnutrition and complications, to determine the association between biomarkers
(pre-albumin, albumin, C-reactive protein [CRP]) and malnutrition and lastly,
to assess the relationship between malnutrition and long term outcomes.
Study objective
The primary objective is to investigate whether polytrauma patients (Injury
Severity Score [ISS] >= 16) admitted to the ICU who have or develop malnutrition
have a higher complication rate than patients who are and remain
well-nourished. Secondary aims are to determine the prevalence of pre-existent
malnutrition, the incidence of in-hospital developed malnutrition and the
predictive value of (bio)markers for malnutrition.
Study design
This observational prospective cohort study will be performed at three Level-1
trauma centers in the United States and two Level-1 centers in the Netherlands.
The three centers in the United States are Massachusetts General Hospital (MGH)
and Brigham and Women*s Hospital in Boston, and Ryder Trauma Center in Miami.
The two participating Dutch centers are locations of the Trauma Center West
Netherlands, and include Leiden University Medical Center (LUMC) in Leiden and
Haaglanden Medical Center Westeinde in The Hague.
Study burden and risks
This observational study poses no additional burden, risk and benefits for the
study participants.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• >=18 years of age
• Polytrauma patient (Injury Severity Score >=16)
• Blunt trauma mechanism
• Admitted to the ICU
Exclusion criteria
• <48hr admission to the intensive care unit
• Transfer from other hospital to participating center
• Patients with burn wounds
• Penetrating trauma mechanism
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL64016.058.17 |