TICACOS International (P2 -RMCS)
Recruitment status was: Recruiting
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.
|Mechanical Ventilation Complication||Dietary Supplement: Indirect Calorimetry measurement of Resting Energy Expenditure .|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Diagnostic
|Official Title:||Tight Caloric Balance in ICU Patients: a Multicenter, Prospective, Randomized, Controlled Study.|
- Rate of nosocomial infections [ Time Frame: After 48 to 72 hours /daily assessment: within 28 day ]Rate of nosocomial infections acquired after 48 to 72 hours following admission up to day 28/or discharge will be evaluated
- Metabolic control [ Time Frame: Day 1 up to day 28/or discharge ]Glucose concentration, insulin administration, rate of hypoglycemic events will be daily assessed
- Caloric control [ Time Frame: Day 1 up to day 28/or discharge ]Success of tight caloric control:accumulative and maximum negative energy balance
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
No Intervention: Control group
Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the "liberal " regimen, i.e. according to local practice.
Experimental: Indirect Calorimetry
Study group: Indirect Calorimetry (IC) 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 measurement of Resting Energy Expenditure (REE).
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.
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.
Rate of nosocomial infections (for definitions see appendage 1) acquired after 48 to 72 hours following admission.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479673
|Contact: Pierre Singer, MD,Professorfirstname.lastname@example.org|
|Contact: Milana Grinev, RNemail@example.com|
|Rabin Medical Center, Campus Beilinson||Recruiting|
|Petach Tikva, Israel, 49100|
|Contact: Pierre Singer, Professor ,MD 972-39376521 firstname.lastname@example.org|
|Contact: Milana Grinev, Study Coordinator 972-39376590 email@example.com|
|Sub-Investigator: Ilya Kagan, MD|
|Sub-Investigator: Ronit Anbar, RD|
|Principal Investigator:||Pierre Singer, MD, Professor||RabinMC,Beilinson Hospital|
|Study Director:||Milana Grinev, RN,Study Coordinator||RabinMC, Beilinson Hospital ,Petah- Tikva, Israel|