Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238674
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2024-01-07
Brief Title:
Early Goal Nutrition Therapy Guided by Indirect Calorimetry and Nitrogen Balance Among Critically Ill Patients With Acute Kidney Injury ENGINE Study
Sponsor:
Wankawee Jeerangsapasuk
Organization:
Thammasat University
Study Overview
Official Title:
Early Goal Nutrition Therapy Guided by Indirect Calorimetry and Nitrogen Balance Among Critically Ill Patients With Acute Kidney Injury
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENGINE
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 randomization48-72 days after admissions with total energy guided by indirect calorimetry measurements and total protein by nitrogen balance with maximum of 13 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
type of study clinical trial Participants will be provided enteral or parenteral nutrition after randomization48-72 days after admissions with total energy guided by indirect calorimetry measurements and total protein by nitrogen balance with maximum of 13 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 calorimetryIC 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 injuryAKI 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 13 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
As there are no high-quality studies that investigated energy and protein provision in hospitalized patients with acute kidney injuryAKI 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 13 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None