NCT01479673

TICACOS International

Tight Caloric Balance in ICU Patients: a Multicenter, Prospective, Randomized, Controlled Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Mechanical Ventilation Complication

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Indirect Calorimetry measurement of Resting Energy Expenditure .	Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the individual energy requirements calculated by Indirect Calorimetry.

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-11-24
• Last updated: 2013-11-25

Locations

1 site across 1 country: Israel