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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic


Related Conditions & MeSH terms

  • Mechanical Ventilation Complication

NCT number NCT01479673
Study type Interventional
Source Rabin Medical Center
Contact Pierre Singer, MD,Professor
Phone 972-3-9376521
Email psinger@clalit.org.il
Status Recruiting
Phase N/A
Start date November 2011
Completion date December 2014

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