Impact of SPN on Infection Rate, Duration of Mechanical Ventilation & Rehabilitation in ICU Patients
|Study Design:||Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Supportive Care|
Dietary Supplement: SPN
|Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations|
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|Significant events and approaches for the overall study following participant enrollment, but prior to group assignment|
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|Control Group||EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.|
experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.
In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.
SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line.
Participant Flow: Overall Study
|Control Group||SPN Group|
|1. Primary:||Documented Infection Rate [ Time Frame: 20 days ]|
|2. Secondary:||Hours on Mechanical Ventilation in All Patients [ Time Frame: 28 days ]|
|3. Secondary:||Antibiotic Free Days [ Time Frame: 20 days ]|
|4. Secondary:||Total Energy Intake During the Intervention Period , Between Day 4 and Day 8. [ Time Frame: 5 days ]|
|5. Secondary:||General Mortality [ Time Frame: 28 days ]|
|6. Secondary:||Days in ICU [ Time Frame: 28 days ]|
|7. Secondary:||ICU Mortality [ Time Frame: 28 days ]|
|8. Secondary:||Protein Delivery During the Intervention Period From Day 4 to Day 8 [ Time Frame: 5 days ]|
|9. Secondary:||Days in Hospital [ Time Frame: 28 days ]|
Limitations and Caveats