Acute Kidney Injury, Critically Ill, Nutrition Disorders
Conditions
Keywords
Indirect calorimetry, nutrition in acute kidney injury, nutrition in critically ill, nitrogen balance
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
Interventions
OTHERindirect calorimetry and nitrogen balance
nutrition therapy with energy guided by indirect calorimetry measurements and total protein guided by nitrogen balance with the maximum of 1.3 g/kg/d , repeated indirect calorimetry if renal replacement therapy was initiated and follow up of urea nitrogen balance after 7 days of intervention to guarantee positive nitrogen balance
indirect calorimetry measurements using the Q-NRG+ device will be conducted and urea nitrogen balance were measured . In the standard care nutrition arm, clinicians will be blinded to indirect calorimetry and urea nitrogen balance measurements
Sponsors
Thammasat University Hospital
Wankawee Jeerangsapasuk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28 day mortality | up to 28 days after randomization | 28 day mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU mortality | up to 28 days | ICU mortality |
| Rate of new renal replacement therapy | up to 28 days | Rate of new renal replacement therapy (times) |
| 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) |
| length of ICU stay | up to 28 days | Duration of ICU stay (days) |
| 60 day mortality | up to 60 days | 60 day mortality |
| 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 |
| adverse events | up to 28 days | feeding intolerance, diarrhea (percent) |
| Blood sugar level and amount of insulin usage | up to 28 days | average amount of daily amount of insulin usage (unit) |
Countries
Thailand
Outcome results
None listed