Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
560 participants
INTERVENTIONAL
2011-11-30
2014-12-31
Brief Summary
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Study Design :Multi-center, randomized, single blinded, controlled study. Study Population: newly-admitted, adult mechanically ventilated ICU patients.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
No interventions assigned to this group
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Rabin Medical Center
OTHER
Responsible Party
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Pierre singer
Professor Pierre Singer, MD
Principal Investigators
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Pierre Singer, MD, Professor
Role: PRINCIPAL_INVESTIGATOR
RabinMC,Beilinson Hospital
Milana Grinev, RN,Study Coordinator
Role: STUDY_DIRECTOR
RabinMC, Beilinson Hospital ,Petah- Tikva, Israel
Locations
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Rabin Medical Center, Campus Beilinson
Petah Tikva, Petach Tikva, Israel
Countries
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Central Contacts
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Facility Contacts
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Pierre Singer, Professor,MD
Role: primary
Milana Grinev, Study Coordinator
Role: backup
Other Identifiers
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4329
Identifier Type: -
Identifier Source: org_study_id