Clinical trial NCT06238674: Early Goal Nutrition Therapy Guided by Indirect Calorimetry and Nitrogen Balance Among Critically Ill Patients With Acute Kidney Injury (ENGINE Study)
Official title: Early Goal Nutrition Therapy Guided by Indirect Calorimetry and Nitrogen Balance Among Critically Ill Patients With Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Critically Ill
Nutrition Disorders
Acute Kidney Injury
Keywords: Indirect calorimetry, nutrition in acute kidney injury, nutrition in critically ill, nitrogen balance
Lead sponsor: Thammasat University
Sponsor class: OTHER
Collaborators: name: Thammasat University Hospital
First posted: 2024-02-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 28 day mortality
timeFrame: up to 28 days after randomization
Secondary outcomes:
measure: length of ICU stay
timeFrame: up to 28 days
measure: ICU mortality
timeFrame: up to 28 days
measure: Rate of new renal replacement therapy
timeFrame: up to 28 days
measure: Peak serum creatinine
timeFrame: up to 28 days
measure: Nosocomial infection
timeFrame: up to 28 days
measure: Blood sugar level and amount of insulin usage
timeFrame: up to 28 days
measure: 60 day mortality
timeFrame: up to 60 days
measure: Duration of mechanical ventilation
timeFrame: up to 28 days
measure: Treatment separation in energy adequacy
timeFrame: up to 28 days
measure: adverse events
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Rangsit
country: Thailand
facility: Thammasat University Hospital
state: Pathumthani
Study officials:
affiliation: Thammasat University Hospital
name: Wankawee Jeerangsapasuk, Bachelor
role: STUDY_DIRECTOR
References:
citation: Susantitaphong P, Cruz DN, Cerda J, Abulfaraj M, Alqahtani F, Koulouridis I, Jaber BL; Acute Kidney Injury Advisory Group of the American Society of Nephrology. World incidence of AKI: a meta-analysis. Clin J Am Soc Nephrol. 2013 Sep;8(9):1482-93. doi: 10.2215/CJN.00710113. Epub 2013 Jun 6.
citation: Uchino S, Bellomo R, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-van Straaten H, Ronco C, Kellum JA. Continuous renal replacement therapy: a worldwide practice survey. The beginning and ending supportive therapy for the kidney (B.E.S.T. kidney) investigators. Intensive Care Med. 2007 Sep;33(9):1563-70. doi: 10.1007/s00134-007-0754-4. Epub 2007 Jun 27.
citation: Fiaccadori E, Sabatino A, Barazzoni R, Carrero JJ, Cupisti A, De Waele E, Jonckheer J, Singer P, Cuerda C. ESPEN guideline on clinical nutrition in hospitalized patients with acute or chronic kidney disease. Clin Nutr. 2021 Apr;40(4):1644-1668. doi: 10.1016/j.clnu.2021.01.028. Epub 2021 Feb 9.