Status:
UNKNOWN
TICACOS International
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Mechanical Ventilation Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 nut...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT01479673
Start Date
November 1 2011
End Date
December 1 2014
Last Update
November 25 2013
Active Locations (1)
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1
Rabin Medical Center, Campus Beilinson
Petah Tikva, Petach Tikva, Israel, 49100