Mechanical Ventilation Complication Clinical Trial
Official title:
Tight Caloric Balance in ICU Patients: a Multicenter, Prospective, Randomized, Controlled Study.
The aim of this study is to perform a prospective, randomized, controlled blinded study in
critically patients to assess the necessity for measuring daily resting energy expenditure
as a guide for nutritional support. Our hypothesis is that tight caloric control will reduce
the rate of new infections.
Study Design :Multi-center, randomized, single blinded, controlled study. Study Population:
newly-admitted, adult mechanically ventilated ICU patients.
Study objectives
To evaluate the effect of tight caloric control in critical patients on:
- The rate of acquired nosocomial infections (Ventilated associated pneumonia, Catheter
related infections, Urinary tract infections)
- Mortality rates, length of stay in the ICU and in hospital, length of ventilation and
incidence of non-infectious complications.
Primary endpoint:
Rate of nosocomial infections (for definitions see appendage 1) acquired after 48 to 72
hours following admission.
Secondary endpoints
- Metabolic control: glucose concentration, insulin administration, rate of hypoglycemic
events.
- Success of tight caloric control: accumulative and maximum negative energy balance.
- Organ function: SOFA score.
- Rate of non-infectious complications: requirement for surgery or occurrence of pressure
sores.
- Length of ICU stay and of assisted ventilation (LOS and LOV)
- ICU survival rate.
- Patient status and disposition on day 28 or at hospital discharge.
- 3 & 6 months survival.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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