TICACOS International

Mechanical Ventilation Complication Clinical Trial

— P2 -RMCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01479673
• Other study ID #: 4329
• Status: Recruiting
• Phase: N/A
• First received: November 22, 2011
• Last updated: November 21, 2013
• Start date: November 2011
• Est. completion date: December 2014

Study information

• Verified date: November 2013
• Source: Rabin Medical Center
• Contact: Pierre Singer, MD,Professor
• Phone: 972-3-9376521
• Email: psinger[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Campus Beilinson	Petach Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Baxter Healthcare Corporation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Metabolic control	Glucose concentration, insulin administration, rate of hypoglycemic events will be daily assessed	Day 1 up to day 28/or discharge	No
Secondary	Caloric control	Success of tight caloric control:accumulative and maximum negative energy balance	Day 1 up to day 28/or discharge	No