TICACOS International (P2 -RMCS)

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

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 Overview

• Status: Unknown
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Dietary supplement: Indirect Calorimetry measurement of Resting Energy Expenditure .

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel, 49100
    • Recruiting
    • Rabin Medical Center, Campus Beilinson
    • Contact: Pierre Singer, Professor,MD; Phone Number: 972-39376521; Email: psinger@clalit.org.il
    • Sub-Investigator: Ronit Anbar, RD
    • Contact: Milana Grinev, Study Coordinator; Phone Number: 972-39376590; Email: milang@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Pierre Singer, MD, Professor, RabinMC,Beilinson Hospital; Study Director: Milana Grinev, RN,Study Coordinator, RabinMC, Beilinson Hospital ,Petah- Tikva, Israel

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 23, 2011
• First Posted (Estimate): November 24, 2011

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 21, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Enteral Nutrition; Parenteral Nutrition; Indirect Calorimetry; Intravenous Feeding
• Other Study ID Numbers: 4329