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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Nutrition Disorders; Acute Kidney Injury; Critically Ill
• Intervention / Treatment: Other: indirect calorimetry and nitrogen balance; Other: Indirect calorimetry (Standard care nutrition arm)

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Thailand
  • Pathumthani
    • Rangsit, Pathumthani, Thailand, 12121
      • Thammasat University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individualised energy and protein delivery guided by 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	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; Other Names: Metabolic demand
Active Comparator: Standard care nutrition; Energy and protein delivery will be according to predictive equation estimates and usual site practice along enteral feeding	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28 day mortality	28 day mortality	up to 28 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of ICU stay	Duration of ICU stay (days)	up to 28 days
ICU mortality	ICU mortality	up to 28 days
Rate of new renal replacement therapy	Rate of new renal replacement therapy (times)	up to 28 days
Peak serum creatinine	Peak serum creatinine (mg/dl)	up to 28 days
Nosocomial infection	incident of Nosocomial infection (yes or No)	up to 28 days
Blood sugar level and amount of insulin usage	average amount of daily amount of insulin usage (unit)	up to 28 days
60 day mortality	60 day mortality	up to 60 days
Duration of mechanical ventilation	Duration of mechanical ventilation (days)	up to 28 days
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
adverse events	feeding intolerance, diarrhea (percent)	up to 28 days

Collaborators and Investigators

• Sponsor: Wankawee Jeerangsapasuk
• Collaborators: Thammasat University Hospital
• Investigators: Study Director: Wankawee Jeerangsapasuk, Bachelor, Thammasat University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Estimated): March 15, 2024
• Study Completion (Estimated): March 28, 2024

Study Registration Dates

• First Submitted: January 7, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Estimated): February 2, 2024

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Indirect calorimetry, nutrition in acute kidney injury, nutrition in critically ill, nitrogen balance
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Critical Illness; Acute Kidney Injury; Nutrition Disorders
• Other Study ID Numbers: MTU-EC-IM-0-281/65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing requests will be considered following publication of the primary trial data on an individual basis by the trial management committee (the data custodians). Data sharing will only be considered for investigator-initiated, independent researchers who provide a written data evaluation proposal that is judged to be methodologically sound. A data sharing agreement will be required to detail conditions under which data is shared and used. Resulting publications should appropriately cite and acknowledge the original data custodians. Requests for data sharing are to be made to wankaweej@gmail.com and the corresponding author, Dr Aphichat Chatkrailert; tengaphi@gmail.com
• IPD Sharing Access Criteria: depend on responsible party agreements
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No