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

NCT06238674 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: MTU-EC-IM-0-281/65
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Critically Ill; Nutrition Disorders; Acute Kidney Injury

Keywords

Indirect calorimetry, nutrition in acute kidney injury, nutrition in critically ill, nitrogen balance

Outcome Measures

Primary Outcomes (1)

• 28 day mortality

  28 day mortality

  up to 28 days after randomization

Secondary Outcomes (10)

• length of ICU stay

  up to 28 days

• ICU mortality

  up to 28 days

• Rate of new renal replacement therapy

  up to 28 days

• Peak serum creatinine

  up to 28 days

• Nosocomial infection

  up to 28 days

Study Arms (2)

Individualised energy and protein delivery guided by indirect calorimetry and nitrogen balance

EXPERIMENTAL

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

Standard care nutrition

ACTIVE COMPARATOR

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)

Interventions

indirect calorimetry and nitrogen balance OTHER

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

Also known as: Metabolic demand

Individualised energy and protein delivery guided by indirect calorimetry and nitrogen balance

Indirect calorimetry (Standard care nutrition arm) OTHER

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

Standard care nutrition

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wankawee Jeerangsapasuk: lead
• Thammasat University Hospital: collaborator

Study Sites (1)

Thammasat University Hospital

Rangsit City Municipality, Changwat Pathum Thani, 12121, Thailand

Location

Related Publications (3)

• 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.

  PMID: 23744003 BACKGROUND

• 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.

  PMID: 17594074 BACKGROUND

• 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.

  PMID: 33640205 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Nutrition Disorders; Acute Kidney Injury

Interventions

Calorimetry, Indirect

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Calorimetry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Wankawee Jeerangsapasuk, Bachelor

  Thammasat University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical nephrology fellow, Principal Investigator, Doctor

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: February 2, 2024
• Study Start: March 7, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 28, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Access Criteria: depend on responsible party agreements

Locations

TH (1)