Early Goal Nutrition Therapy Guided by Indirect Calorimetry and Nitrogen Balance Among Critically Ill Patients With Acute Kidney Injury (ENGINE Study)

Acute Kidney Injury Clinical Trial

— ENGINE  

Official title:

Early Goal Nutrition Therapy Guided by Indirect Calorimetry and Nitrogen Balance Among Critically Ill Patients With Acute Kidney Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06238674
• Other study ID #: MTU-EC-IM-0-281/65
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: March 7, 2023
• Est. completion date: March 28, 2024

Study information

• Verified date: February 2024
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: March 28, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Critically Ill
• Nutrition Disorders
• Wounds and Injuries

Intervention

Other:
• indirect 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 (Standard care nutrition arm)
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

Locations

Country	Name	City	State
Thailand	Thammasat University Hospital	Rangsit	Pathumthani

Sponsors (2)

Lead Sponsor	Collaborator
Wankawee Jeerangsapasuk	Thammasat University Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View 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. Erratum In: Clin J Am Soc Nephrol. 2014 Jun 6;9(6):1148. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 day mortality	28 day mortality	up to 28 days after randomization
Secondary	length of ICU stay	Duration of ICU stay (days)	up to 28 days
Secondary	ICU mortality	ICU mortality	up to 28 days
Secondary	Rate of new renal replacement therapy	Rate of new renal replacement therapy (times)	up to 28 days
Secondary	Peak serum creatinine	Peak serum creatinine (mg/dl)	up to 28 days
Secondary	Nosocomial infection	incident of Nosocomial infection (yes or No)	up to 28 days
Secondary	Blood sugar level and amount of insulin usage	average amount of daily amount of insulin usage (unit)	up to 28 days
Secondary	60 day mortality	60 day mortality	up to 60 days
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation (days)	up to 28 days
Secondary	Treatment separation in energy adequacy	Energy adequacy % will be calculated as energy delivery (kcal)/ measured energy expenditure (kcal) and expressed as a percentage	up to 28 days
Secondary	adverse events	feeding intolerance, diarrhea (percent)	up to 28 days