Early Goal Nutrition Therapy Guided by Indirect Calorimetry and Nitrogen Balance Among Critically Ill Patients With Acute Kidney Injury (ENGINE Study)
- Conditions
- Critically IllNutrition DisordersAcute Kidney Injury
- Interventions
- Other: Indirect calorimetry (Standard care nutrition arm)Other: indirect calorimetry and nitrogen balance
- Registration Number
- NCT06238674
- Lead Sponsor
- Wankawee Jeerangsapasuk
- Brief Summary
The goal of this clinical trial is to investigate the effects of nutrition therapy guided by indirect calorimetry and nitrogen balance among critically ill patients with acute kidney injury. The main question it aims to answer whether nutrition therapy guided by indirect calorimetry and nitrogen balance could improve 28 days mortality among critically ill patients with acute kidney injury or not.
type of study: clinical trial Participants will be provided enteral or parenteral nutrition after randomization(48-72 days after admissions) with total energy guided by indirect calorimetry measurements and total protein by nitrogen balance with maximum of 1.3 gram per kilogram per day for total of 14 days If there is a comparison group: Researchers will compare with the control groups (nutrition therapy provided by physician using clinical equation of choice or judgements to see if participants were provided with these interventions, their 28 days mortalities would be better
- Detailed Description
The gold standard for determining energy requirements was recommended by the European Society for Parenteral and Enteral Nutrition (ESPEN) guideline 2021 to use indirect calorimetry(IC), a noninvasive method that allows resting energy expenditure (REE) evaluation based on measurements of oxygen consumption and carbon dioxide production in the exhaled air.
As there are no high-quality studies that investigated energy and protein provision in hospitalized patients with acute kidney injury(AKI) or Acute kidney disease (AKD), the recommendations were based on the guidelines and clinical trials from critically ill and polymorbid internal medicine patients because these guidelines and trials included patients with kidney disease.
Moreover, there were clinical trials in critically ill patients with severe acute kidney injury found the varying of metabolic states among these patients categorized by IC measurements and no association between calorie intake and mortality outcome.
Even though the aforementioned researches did not suggest a link between calorie intake and mortality outcome, no studies were able to meet the energy targets set using indirect calorimetry measurements.
This study aims to prove the necessary and benefit of early nutrition therapy after 72 hours of admission with total energy guided by indirect calorimetry measurements aims to meet 70-100% from measurements and total protein guided by urine urea nitrogen balance aims to positive nitrogen balance with maximum of 1.3 gram per kilogram of actual body weight per day for total of 14 days on survival \& renal outcomes in critically ill patients with acute kidney injury
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Age 18-90 years old
- Mechanically ventilated patients with acute kidney injury by Kidney Disease Improving Global Outcomes (KDIGO) criteria
- Expected length of ICU stay more than 72 hours and accept to follow the study protocol
- Underlying chronic kidney disease stage 4 or 5 according to KDIGO staging
- received renal replacement therapy prior to admission
- Post cardiothoracic surgery
- Required fraction of inspired oxygen inspired oxygen fraction (FiO2) more than 0.6
- Pregnancy
- BMI below 17 or above 35 kg/m2 or very high risk refeeding syndrome
- Cirrhosis Child-Pugh score C
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care nutrition Indirect calorimetry (Standard care nutrition arm) Energy and protein delivery will be according to predictive equation estimates and usual site practice along enteral feeding Individualised energy and protein delivery guided by indirect calorimetry and nitrogen balance indirect calorimetry and nitrogen balance Energy delivery will be guided by indirect calorimetry with the aim to meet 70-100% of the most recent energy expenditure measurement and protein delivery guided by nitrogen balance with the aim to positive nitrogen balance with the maximum of 1.3 g/kg/d after 72 hours of admission and continue for total of 14 days by enteral or parenteral feeding routes
- Primary Outcome Measures
Name Time Method 28 day mortality up to 28 days after randomization 28 day mortality
- Secondary Outcome Measures
Name Time Method adverse events up to 28 days feeding intolerance, diarrhea (percent)
length of ICU stay up to 28 days Duration of ICU stay (days)
Rate of new renal replacement therapy up to 28 days Rate of new renal replacement therapy (times)
60 day mortality up to 60 days 60 day mortality
Peak serum creatinine up to 28 days Peak serum creatinine (mg/dl)
Nosocomial infection up to 28 days incident of Nosocomial infection (yes or No)
ICU mortality up to 28 days ICU mortality
Blood sugar level and amount of insulin usage up to 28 days average amount of daily amount of insulin usage (unit)
Duration of mechanical ventilation up to 28 days Duration of mechanical ventilation (days)
Treatment separation in energy adequacy up to 28 days Energy adequacy % will be calculated as energy delivery (kcal)/ measured energy expenditure (kcal) and expressed as a percentage
Trial Locations
- Locations (1)
Thammasat University Hospital
🇹đź‡Rangsit, Pathumthani, Thailand