TICACOS International

Rabin Medical Center560 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

560

Conditions

Mechanical Ventilation Complication

Interventions

Indirect Calorimetry measurement of Resting Energy Expenditure .DIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Mechanically-ventilated adults(Male or Female)admitted to general ICU within the first 48 hours of ICU admission. 2. Age ≥ 18 years;no upper age limit. 3. Expected stay in ICU\> 3 days: \[SAPS II (18) \> ICU median or high-level of nursing care implemented or per clinical impression of attending physician\] 4. Medical and abdomino/thoracic surgery patients, as well as multiple trauma patients with Glasgow Coma Score ≥ 10. Exclusion Criteria: 1. Pregnancy. 2. DNR order. 3. Readmission in the ICU during the same hospitalization/transfer from other ICU. 4. Admission for postoperative monitoring. 5. Respiratory instability: SpO2 \<90% or need for ventilator adjustments during the preceding hour or hyperventilation (Respiratory rate \> 35/min) 6. Bicarbonate infusion, loss of bicarbonate (diarrhea, ureterosogmoidostomy or use of acetazoloamide, ultrafiltration). 7. Aerosolization with nitric oxide or heliox, tracheal insufflations or visible leaks in chest drainage system. 8. FiO2 80% or patients requiring prone position 9. Chronic/acute liver failure:Child-Pugh class C 10. Brain injury for various reasons with Glasgow Coma Scale below 10. 11. Cardiac surgery patients. 12. Patients in the hospital for more than 7 days. 13. Contra indication to use enteral nutrition. 14. Participation in a clinical study with an investigational drug within one month prior to the start of this clinical trial. 15. Ethical issues that will influence subject eligibility.

Locations (1)

Rabin Medical Center, Campus Beilinson

Petah Tikva, Petach Tikva, Israel

RECRUITING

Outcomes

Primary Outcomes

Rate of nosocomial infections

Rate of nosocomial infections acquired after 48 to 72 hours following admission up to day 28/or discharge will be evaluated

Time frame: After 48 to 72 hours /daily assessment: within 28 day

Secondary Outcomes

Metabolic control

Glucose concentration, insulin administration, rate of hypoglycemic events will be daily assessed

Time frame: Day 1 up to day 28/or discharge

Caloric control

Success of tight caloric control:accumulative and maximum negative energy balance

Time frame: Day 1 up to day 28/or discharge

Central Contacts

Pierre Singer, MD,Professor

CONTACT

972-3-9376521 psinger@clalit.org.il

Milana Grinev, RN

CONTACT

972-3-9376521 milang@clalit.org.il

Data from ClinicalTrials.gov

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