Critically IllPhase 1/2ENGINENCT06238674
Early Goal Nutrition Therapy Guided by Indirect Calorimetry and Nitrogen Balance Among Critically Ill Patients With Acute Kidney Injury (ENGINE Study)
A Phase 1/2 study testing indirect calorimetry and nitrogen balance in people with Critically Ill and Nutrition Disorders, run by Wankawee Jeerangsapasuk at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critically Ill, Nutrition Disorders, Acute Kidney Injury
- What is being tested?
- indirect calorimetry and nitrogen balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 7 Mar 2023to 28 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University Hospital
Rangsit City Municipality, Changwat Pathum Thani, 12121
About this study
Official title: 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
Read the 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
- Conditions
- Critically Ill, Nutrition Disorders, Acute Kidney Injury
- Being tested
- indirect calorimetry and nitrogen balance, Indirect calorimetry (Standard care nutrition arm)
- Keywords
- Indirect calorimetry, nutrition in acute kidney injury, nutrition in critically ill, nitrogen balance
- Medical subject headings
- Critical Illness, Nutrition Disorders, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indirect calorimetry and nitrogen balanceOther
Also called Metabolic demand
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)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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Indirect calorimetry (Standard care nutrition arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day mortality
28 day mortality
Measured: up to 28 days after randomization
Secondary outcomes (10)
length of ICU stay
Duration of ICU stay (days)
Measured: up to 28 days
ICU mortality
ICU mortality
Measured: up to 28 days
Rate of new renal replacement therapy
Rate of new renal replacement therapy (times)
Measured: up to 28 days
Peak serum creatinine
Peak serum creatinine (mg/dl)
Measured: up to 28 days
Nosocomial infection
incident of Nosocomial infection (yes or No)
Measured: up to 28 days
Blood sugar level and amount of insulin usage
average amount of daily amount of insulin usage (unit)
Measured: up to 28 days
60 day mortality
60 day mortality
Measured: up to 60 days
Duration of mechanical ventilation
Duration of mechanical ventilation (days)
Measured: 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
Measured: up to 28 days
adverse events
feeding intolerance, diarrhea (percent)
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start7 Mar 2023
- Primary completion15 Mar 2024 (estimated)
- Study completion28 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wankawee Jeerangsapasuk
- Sponsor type
- University, hospital or other
- Collaborators
- Thammasat University Hospital
- Responsible party
- Sponsor-investigator, Wankawee Jeerangsapasuk, Thammasat University
- Investigators
- Wankawee Jeerangsapasuk, Bachelor, Study director, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238674
- Sponsor's protocol ID
- MTU-EC-IM-0-281/65
- Acronym
- ENGINE
- Status last verified
- Feb 2024
- First submitted
- 7 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 23744003Uchino 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.
PubMed 17594074Fiaccadori 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.
PubMed 33640205
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Goal Nutrition Therapy Guided by Indirect Calorimetry and Nitrogen Balance Among Critically Ill Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT06238674
- Acronym / sponsor ID
- ENGINE / MTU-EC-IM-0-281/65
- Conditions
- Critically Ill, Nutrition Disorders, Acute Kidney Injury
- Keywords
- Indirect calorimetry, nutrition in acute kidney injury, nutrition in critically ill, nitrogen balance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Wankawee JeerangsapasukUniversity, hospital or other
- Collaborators
- Thammasat University Hospital
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 28 Mar 2024 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualised energy and protein delivery guided by indirect calorimetry and nitrogen balance | Experimental | Other: indirect calorimetry and nitrogen balanceEnergy 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 |
| Standard care nutrition | Active comparator | Other: Indirect calorimetry (Standard care nutrition arm)Energy and protein delivery will be according to predictive equation estimates and usual site practice along enteral feeding |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indirect calorimetry and nitrogen balanceAlso: Metabolic demandnutrition 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 | Individualised energy and protein delivery guided by indirect calorimetry and 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 | Other | Standard care nutrition |
Primary outcome
28 day mortality
Time frame: up to 28 days after randomization
28 day mortality
10 secondary outcomes
length of ICU stay
Time frame: up to 28 days
ICU mortality
Time frame: up to 28 days
Rate of new renal replacement therapy
Time frame: up to 28 days
Peak serum creatinine
Time frame: up to 28 days
Nosocomial infection
Time frame: up to 28 days
Blood sugar level and amount of insulin usage
Time frame: up to 28 days
60 day mortality
Time frame: up to 60 days
Duration of mechanical ventilation
Time frame: up to 28 days
Treatment separation in energy adequacy
Time frame: up to 28 days
adverse events
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Background: PubMed 23744003Susantitaphong 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.
- Background: PubMed 17594074Uchino 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.
- Background: PubMed 33640205Fiaccadori 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wankawee Jeerangsapasuk, Bachelor study director
Thammasat University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing indirect calorimetry and nitrogen balance in people with Critically Ill and Nutrition Disorders, run by Wankawee Jeerangsapasuk at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day mortality (time frame: up to 28 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06238674, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.