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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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 objectives
To evaluate the effect of tight caloric control in critical patients on:
Primary endpoint:
Rate of nosocomial infections (for definitions see appendage 1) acquired after 48 to 72 hours following admission.
Secondary endpoints
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | 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. | |
| Indirect Calorimetry | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indirect Calorimetry measurement of Resting Energy Expenditure . | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Singer, MD,Professor | Contact | 972-3-9376521 | psinger@clalit.org.il | |
| Milana Grinev, RN | Contact | 972-3-9376521 | milang@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Singer, MD, Professor | RabinMC,Beilinson Hospital | Principal Investigator |
| Milana Grinev, RN,Study Coordinator | RabinMC, Beilinson Hospital ,Petah- Tikva, Israel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center, Campus Beilinson | Recruiting | Petah Tikva | Petach Tikva | 49100 | Israel |
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| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Day 1 up to day 28/or discharge |