TICACOS International

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mechanical Ventilation Complication

Intervention / Treatment
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* Dietary Supplement: Indirect Calorimetry measurement of Resting Energy Expenditure .


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>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<br>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 .<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | After 48 to 72 hours /daily assessment: within 28 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic control | Glucose concentration, insulin administration, rate of hypoglycemic events will be daily assessed | Day 1 up to day 28/or discharge | 
| Caloric control | Success of tight caloric control:accumulative and maximum negative energy balance | Day 1 up to day 28/or discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral Nutrition, Parenteral Nutrition, Indirect Calorimetry, Intravenous Feeding