Bolus Versus Continuous Enteral Tube Feeding
Ключові слова
Анотація
Опис
The trial has been designed in accordance with the Recommendations for Interventional Trials (SPIRIT 2013) and the Consolidated Standards for Reporting of Trials CONSORT guidelines.
Patients who meet the study inclusion criteria (severe trauma patients, surgical patients and medical patients with sepsis, with inserted nasogastric/nasoduodenal feed-ing tube) will be eligible to participate, especially patients who are mechanically ventilated. The last criterion is not a necessary precondition (a module of indirect calorimetry will be used in these patients). The necessary condition is the elimination of shock within 24 hours from the ICU admission and tolerance of trophic enteral feed-ing (20ml/hour) at for the period of at least 24 hours. Patients will be randomized in a ratio of 1:1 within 72 hours of their admission to receive bolus or continuous enteral feeding (sealed envelopes method). In both groups, the same goals of energy and protein will be observed (Day 1-2: E 15 kcal/kg/day, protein 0.8-1 g/kg/day; Day 3-4: E 20 kcal/kg/day, protein 1. 2 g/kg/day; Day ≥ 5: E 25 kcal/kg/day, protein 1.5-2 g/kg/day), according to protocol. The bolus enteral group will receive the amount of enteral nutrition in six boluses (per 60min dose), the continuous enteral group will receive the amount using a pump, within the timeframe of 6am-24pm. The need for parenteral nutrition will be determined by treating clinical staff independently to group allocation.
Demographic data collection: (weight, high, BMI) and conditions (trauma, surgical, medical patients), Acute Physiology and Chronic Health Evaluation (APACHE) Sequential Organ Failure Assessment (SOFA), Nutritional Risk Screening (NRS 2002).
Daily observations: glucose, mean glucose changes, insulin (IU/d), energy and protein intake (administered calories divided by the calculated energy expenditure and administered protein divided by calculated protein intake) - Adjusted/calculated energy and protein (%). Feeding intolerance (tolerating less than 40% of requirements via the enteral route for ≥ 3 days, diarrhea ≥ 500ml per day or five bowel actions). Mechanically ventilated patients (Resting Energy Expenditure (REE) and Respiratory Quotient (RQ) measured with indirect calorimetry) Day 1, 3, 5, 7: Nutritional parameters (serum albumin prealbumin, C-reactive protein (CRP), urine urea, N balance).
Day 1 and 7: Muscle layer thickness (QMLT by ultrasound measurement and mid-upper arm circumference) and muscle strength (dynamometer) from baseline to discharge. Outcomes of muscle strength/ultrasound and dynamometer) will be measured by an investigator blinded to the group allocation.
Дати
Востаннє перевірено: | 08/31/2019 |
Перший поданий: | 09/02/2019 |
Орієнтовна реєстрація подана: | 09/02/2019 |
Опубліковано вперше: | 09/05/2019 |
Останнє оновлення надіслано: | 01/09/2020 |
Останнє оновлення опубліковано: | 01/13/2020 |
Фактична дата початку навчання: | 09/30/2019 |
Розрахункова дата первинного завершення: | 09/29/2021 |
Розрахункова дата завершення дослідження: | 12/30/2021 |
Стан або захворювання
Втручання / лікування
Diagnostic Test: Quadriceps Muscle Layer Fitness
Diagnostic Test: Muscle Strength
Diagnostic Test: Acute Physiology and Chronic Health Evaluation
Diagnostic Test: Sequential Organ Failure Assessment
Diagnostic Test: Nutritional Risk Screening
Diagnostic Test: Energy and Protein Intake
Фаза
Групи рук
Рука | Втручання / лікування |
---|---|
Experimental: Bolus enteral feeding The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions:
Quadriceps Muscle Layer Fitness measurement
Muscle Strength measurement
Acute Physiology and Chronic Health Evaluation
Sequential Organ Failure Assessment
Nutritional Risk Screening
Energy and Protein Intake | |
Experimental: Continuous enteral feeding The patients randomized into this study arm will receive bolus enteral feeding.
The study subjects will undergo the following interventions:
Quadriceps Muscle Layer Fitness measurement
Muscle Strength measurement
Acute Physiology and Chronic Health Evaluation
Sequential Organ Failure Assessment
Nutritional Risk Screening
Energy and Protein Intake |
Критерії прийнятності
Вік, придатний для навчання | 18 Years До 18 Years |
Стать, яка підходить для вивчення | All |
Приймає здорових добровольців | Так |
Критерії | Inclusion Criteria: - polytrauma - major abdominal surgery - sepsis - ICU stay - enteral feeding tube - artificial ventilation Exclusion Criteria: - contraindication of enteral feeding - infaust prognosis - prolonged shock (more than 24 hours) |
Результат
Заходи первинного результату
1. Change in nutritional parameters - serum albumin [7 days]
2. Change in nutritional parameters - prealbumin [7 days]
3. Change in inflammatory parameters - C-reactive protein (CRP) [7 days]
4. Change in muscle mass [7 days]
5. Change in muscle strength [7 days]