TICACOS International (P2 -RMCS)
|ClinicalTrials.gov Identifier: NCT01479673|
Recruitment Status : Unknown
Verified November 2013 by Pierre singer, Rabin Medical Center.
Recruitment status was: Recruiting
First Posted : November 24, 2011
Last Update Posted : November 25, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Mechanical Ventilation Complication||Dietary Supplement: Indirect Calorimetry measurement of Resting Energy Expenditure .||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||560 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Tight Caloric Balance in ICU Patients: a Multicenter, Prospective, Randomized, Controlled Study.|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|