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TICACOS International (P2 -RMCS)

This study is currently recruiting participants.
Verified February 2013 by Rabin Medical Center
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Pierre singer, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01479673
First received: November 22, 2011
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Mechanical Ventilation Complication
 Dietary Supplement: Indirect Calorimetry measurement of Resting Energy Expenditure .

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Tight Caloric Balance in ICU Patients: a Multicenter, Prospective, Randomized, Controlled Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Rate of nosocomial infections [ Time Frame: After 48 to 72 hours /daily assessment: within 28 day ] [ Designated as safety issue: No ]
    Rate of nosocomial infections acquired after 48 to 72 hours following admission up to day 28/or discharge will be evaluated


Secondary Outcome Measures:
  • Metabolic control [ Time Frame: Day 1 up to day 28/or discharge ] [ Designated as safety issue: No ]
    Glucose concentration, insulin administration, rate of hypoglycemic events will be daily assessed

  • Caloric control [ Time Frame: Day 1 up to day 28/or discharge ] [ Designated as safety issue: No ]
    Success of tight caloric control:accumulative and maximum negative energy balance


Estimated Enrollment: 560
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)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479673

Contacts
Contact: Pierre Singer, MD,Professor 972-3-9376521 psinger@clalit.org.il
Contact: Milana Grinev, RN 972-3-9376521 milang@clalit.org.il

Locations
Israel
Rabin Medical Center, Campus Beilinson Recruiting
Petach Tikva, Israel, 49100
Contact: Pierre Singer, Professor ,MD     972-39376521     psinger@clalit.org.il    
Contact: Milana Grinev, Study Coordinator     972-39376590     milang@clalit.org.il    
Sub-Investigator: Ilya Kagan, MD            
Sub-Investigator: Ronit Anbar, RD            
Sponsors and Collaborators
Rabin Medical Center
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
  More Information

No publications provided

Responsible Party: Pierre singer, Professor Pierre Singer, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01479673     History of Changes
Other Study ID Numbers: 4329
Study First Received: November 22, 2011
Last Updated: February 15, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
Enteral Nutrition
Parenteral Nutrition
Indirect Calorimetry
Intravenous Feeding

ClinicalTrials.gov processed this record on May 16, 2013