BACKGROUND: Nutrition plays a significant role in ICU treatment, and may influence mortality and length of stay in ICU. Enteral route (EN) is preferential to parenteral route (PN) in provision of daily nutritional requirements. When enteral route is insufficient, supplemental parenteral nutrition (SPN) is recommended. Optimal timing of SPN in acute phase of illness remains elusive. ICU patients suffer significant lean body mass loss, in majority, in the first 7-10 days of stay. Optimal provision of protein may prevent muscle wasting. Lean body mass is essential for optimal physical functioning after treatment. Although ICU mortality has been reduced lately, the number of patients going to rehabilitation after ICU stay has tripled. Patients after oncological surgery of the gastrointestinal tract may be threatened with impairment of physical functioning after ICU treatment. AIM: To compare the influence of early and late supplemental parenteral nutrition on long-term physical functioning in ICU patients after oncological surgery of the gastrointestinal tract. STUDY DESIGN: Prospective, randomised, multi-centre assessor-blinded study. METHODS \& ANALYSIS: Patients will be randomised into intervention group that would receive SPN on first day, and would be continued until 7th day of stay in ICU. Control group would receive SPN on 7th day of stay in ICU, when it is not then already met via enteral route. Physical Component of SF-36 Scale at 6 month after ICU admission will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
220
Intervention group: would receive EN reaching up to 20 % of daily nutritional requirements and early (on first day of stay in ICU) provision (of up to 80%) of protein (2 g/kg/ day or in case of CRRT 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day) needs in SPN that would be continued until 7th day of stay in ICU. Central venous catheter placement would not be assessed as a part of intervention due to the fact that it is a part of routine medical activities performed during admission to ICU.
2nd Department of Anesthesiology and Critical Care, Medical University of Lublin
Lublin, Lublin Voivodeship, Poland
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
Opole, Silesian Voivodeship, Poland
Long-term quality of life at 3 months
Long-term quality of life measured in physical component of 36 -SF questionnaire
Time frame: Physical component of 36 -SF questionnaire at 3 months after admission to ICU
Long-term quality of life at 6 months
Long-term quality of life measured in physical component of 36 -SF questionnaire
Time frame: Physical component of 36 -SF questionnaire at 6 months after admission to ICU
Enteral route intolerance
Inability to administer up to 60% of protein needs on 3rd day via enteral route
Time frame: At day 3 since admission to ICU
Thickness of diaphragm
Change from baseline in ultrasound measured thickness of diaphragm
Time frame: 1st, 3rd, 5th day of ICU stay
Protein delivery
Protein delivery defined as daily input of proteins via SPN
Time frame: For 7 days since admission to ICU
Energy Intake
Energy delivery defined as daily input of calories via SPN
Time frame: For 7 days since admission to ICU
Insulin dose
Insulin dose defined as summary daily input of insulin
Time frame: For 7 days since admission to ICU
Blood glucose profile
Blood glucose profile defined as mean daily glucose level
Time frame: For 7 days since admission to ICU
Organic phosphorus level
Organic phosphorus level defined as result in blood test performed daily
Time frame: For 7 days since admission to ICU
Sequential Organ Failure Assessment score ( SOFA score)
We will collect data regarding changes from baseline SOFA score - to determine the extent of a person's organ function failure. SOFA scoring system is useful in predicting the clinical outcomes of critically ill patients. Patient can be scored from 0 to 24. If the patient is scored 0 than the patient is in a good state and predicted mortality is low, while 24 is the worst result with expected very high mortality rate.
Time frame: For 28 days since admission to ICU or till discharge
Mechanical Ventilation
Numbers of days of mechanical ventilation
Time frame: For 28 days since admission to ICU or till discharge
Length of stay in the ICU
Numbers of days of patient stay in ICU
Time frame: For 28 days since admission to ICU or till discharge
ICU mortality
Time frame: For 28 days since admission to ICU or till discharge
Hospital mortality
Time frame: For 28 days since admission to ICU or till discharge
Length of stay in hospital
Numbers of days of patient stay in hospital
Time frame: For 28 days since admission to ICU or till discharge
Health-care associated infection
New onset of health-care associated infection
Time frame: For 28 days since admission to ICU or till discharge
Antibiotic-free days
Number of days patient was not given the antibiotics
Time frame: For 28 days since admission to ICU or till discharge
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