Critically IllNCT06244381
Indirect Calorimetry Versus Urea-creatinine Ratio to Evaluate Catabolism in Critically Ill Patients
An observational study of Critically Ill, run by Hospital Sao Domingos at 1 site in Brazil.
Trial summary
This study aims to evaluate the efficiency of the urea/creatinine ratio as a catabolism marker compared to indirect calorimetry to optimize nutritional support in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2024to 1 Oct 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Twenty critically ill COVID-19 patients admitted to a 35-bed ICU intended for patients with COVID-19 from April to August 2021 and who underwent determination of energy expenditure with indirect calorimetry on days 1, 4, 7, 9, 14, 17, and 20 days after admission, and who did not have serum creatinine > 4.0 mg/dL upon admission, were not chronic dialysis patients and did not undergo dialysis treatment during the study period. The urea, creatinine, C-reactive protein, hemoglobin, and albumin results will be obtained from the hospital's electronic medical record during the study period.
Inclusion Criteria: Adult patients with severe COVID-19 submitted to determination of energetic expenditure between the first and twentieth day of ICU stay -
Exclusion Criteria: patients who, upon arrival at the hospital, had a serum creatinine level above 4.0 mg°/dL, chronic kidney disease patients undergoing dialysis, and patients undergoing dialysis treatment during their stay in the ICU.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NUTRITIONAL OPTIMIZATION IN THE DIFFERENT PHASES OF CRITICAL ILLNESS. Comparison of the Urea/Creatinine Ratio With Indirect Calorimetry.
This study aims to evaluate the efficiency of the urea/creatinine ratio as a catabolism marker compared to indirect calorimetry to optimize nutritional support in critically ill patients.
Read the detailed description
The most recent ESPEN guideline on nutritional support in critically ill patients identifies 3 phases in the evolution of critically ill patients: the early acute phase (formerly EBB Phase), characterized by endogenous energy production and activation of autophagy that limits full caloric-protein intake; the late period of the acute phase, when endogenous energy production has reduced to a basal level and autophagy is no longer manifested, and the late or rehabilitation phase. The identification of each of these moments is not based on precise elements. Despite this division into phases, there is no clear evidence of metabolic behavior, especially in the second and third phases, when the catabolic state gives way to anabolism.
Currently, monitoring catabolism is complicated since there is no available biomarker with acceptable sensitivity and specificity. 3-methyl histidine and nitrogen balance are not available in everyday life. As catabolism is not measured, its presence and severity only become apparent when muscle loss and weakness set in.
Recently, Haines et al., analyzing a population of patients with persistent severe disease, who are patients with prolonged hospitalization and with no resolution in the ICU, showed that continued catabolism is their metabolic hallmark and was measured by the urea/creatinine ratio persistently high.
The phases of severe illness could then be defined based on the UCR relationship. The ratio must be high in the early acute and late acute phases and may be a marker of the beginning of the late phase of recovery and anabolism.
Indirect calorimetry, the gold standard for determining energy expenditure energy, has revealed in studies that it can be the marker of the beginning of the anabolic when energy expenditure increases rapidly. This behavior of indirect calorimetry was observed in COVID-19 but has also been demonstrated in other patient populations.
Although indirect calorimetry can represent a reliable measure for determining the beginning of the anabolic phase, it is not a widely available measurement in ICUs, unlike urea and creatinine measurements that are part of routine daily exams in ICUs.
The urea/creatinine ratio may be an efficient catabolism marker to guide nutritional therapy in critically ill patients. Evidence to confirm this hypothesis can be obtained by comparing the urea/creatinine ratio with indirect calorimetry, which is the gold standard for evaluating energy expenditure and catabolism in these patients.
The primary objective will be to correlate the behavior of the urea/creatinine ratio with the energetic expenditure measured by indirect calorimetry in patients with severe forms of COVID-19 to identify the beginning of the anabolic phase that would be translated by a reduction in UCR and an increase in energy expenditure in IC. Secondarily, correlate other catabolism markers with calorimetry results. They are serum albumin, hemoglobin, and C-reactive protein.
- Conditions
- Critically Ill
- Keywords
- Catabolism, Indirect calorimetry, Urea/creatinine ratio, Critically ill, COVID-19
- Medical subject headings
- Critical Illness, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Urea/creatinine ratio
Compare urea/creatinine ratio with indirect calorimetry to determine catabolism and optimize nutritional support in critically ill COVID-19 patients.
Measured: 30 days
Secondary outcomes (3)
Serum albumin
Compare albumin with indirect calorimetry to determine catabolism and optimize nutritional support in critically ill COVID-19 patients.
Measured: 30 days
Hemoglobin concentration
Compare hemoglobin concentration with indirect calorimetry to determine catabolism and optimize nutritional support in critically ill COVID-19 patients.
Measured: 30 days
C-reactive protein
Compare C-reactive protein with indirect calorimetry to determine catabolism and optimize nutritional support in critically ill COVID-19 patients.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Mar 2024
- Primary completion30 Jun 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Domingos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Raimundo Araujo de Azevedo, Hospital Sao Domingos
- Investigators
- JOSE AZEVEDO, MD, PhD, Study director, Hospital São Domingos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244381
- Sponsor's protocol ID
- hsd0124
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singer P, Blaser AR, Berger MM, Calder PC, Casaer M, Hiesmayr M, Mayer K, Montejo-Gonzalez JC, Pichard C, Preiser JC, Szczeklik W, van Zanten ARH, Bischoff SC. ESPEN practical and partially revised guideline: Clinical nutrition in the intensive care unit. Clin Nutr. 2023 Sep;42(9):1671-1689. doi: 10.1016/j.clnu.2023.07.011. Epub 2023 Jul 15.
PubMed 37517372Long CL, Dillard DR, Bodzin JH, Geiger JW, Blakemore WS. Validity of 3-methylhistidine excretion as an indicator of skeletal muscle protein breakdown in humans. Metabolism. 1988 Sep;37(9):844-9. doi: 10.1016/0026-0495(88)90118-7.
PubMed 3138511Haines RW, Zolfaghari P, Wan Y, Pearse RM, Puthucheary Z, Prowle JR. Elevated urea-to-creatinine ratio provides a biochemical signature of muscle catabolism and persistent critical illness after major trauma. Intensive Care Med. 2019 Dec;45(12):1718-1731. doi: 10.1007/s00134-019-05760-5. Epub 2019 Sep 17.
PubMed 31531715Niederer LE, Miller H, Haines KL, Molinger J, Whittle J, MacLeod DB, McClave SA, Wischmeyer PE. Prolonged progressive hypermetabolism during COVID-19 hospitalization undetected by common predictive energy equations. Clin Nutr ESPEN. 2021 Oct;45:341-350. doi: 10.1016/j.clnesp.2021.07.021. Epub 2021 Aug 3.
PubMed 34620338Long CL, Schaffel N, Geiger JW, Schiller WR, Blakemore WS. Metabolic response to injury and illness: estimation of energy and protein needs from indirect calorimetry and nitrogen balance. JPEN J Parenter Enteral Nutr. 1979 Nov-Dec;3(6):452-6. doi: 10.1177/014860717900300609.
PubMed 575168Monk DN, Plank LD, Franch-Arcas G, Finn PJ, Streat SJ, Hill GL. Sequential changes in the metabolic response in critically injured patients during the first 25 days after blunt trauma. Ann Surg. 1996 Apr;223(4):395-405. doi: 10.1097/00000658-199604000-00008.
PubMed 8633918
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUTRITIONAL OPTIMIZATION IN THE DIFFERENT PHASES OF CRITICAL ILLNESS. Comparison of the Urea/Creatinine Ratio With Indirect Calorimetry.
- ClinicalTrials.gov ID
- NCT06244381
- Acronym / sponsor ID
- hsd0124
- Conditions
- Critically Ill
- Keywords
- Catabolism, Indirect calorimetry, Urea/creatinine ratio, Critically ill, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Sao DomingosUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 6 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.
This study aims to evaluate the efficiency of the urea/creatinine ratio as a catabolism marker compared to indirect calorimetry to optimize nutritional support in critically ill patients.
Detailed description
The most recent ESPEN guideline on nutritional support in critically ill patients identifies 3 phases in the evolution of critically ill patients: the early acute phase (formerly EBB Phase), characterized by endogenous energy production and activation of autophagy that limits full caloric-protein intake; the late period of the acute phase, when endogenous energy production has reduced to a basal level and autophagy is no longer manifested, and the late or rehabilitation phase. The identification of each of these moments is not based on precise elements. Despite this division into phases, there is no clear evidence of metabolic behavior, especially in the second and third phases, when the catabolic state gives way to anabolism.
Currently, monitoring catabolism is complicated since there is no available biomarker with acceptable sensitivity and specificity. 3-methyl histidine and nitrogen balance are not available in everyday life. As catabolism is not measured, its presence and severity only become apparent when muscle loss and weakness set in.
Recently, Haines et al., analyzing a population of patients with persistent severe disease, who are patients with prolonged hospitalization and with no resolution in the ICU, showed that continued catabolism is their metabolic hallmark and was measured by the urea/creatinine ratio persistently high.
The phases of severe illness could then be defined based on the UCR relationship. The ratio must be high in the early acute and late acute phases and may be a marker of the beginning of the late phase of recovery and anabolism.
Indirect calorimetry, the gold standard for determining energy expenditure energy, has revealed in studies that it can be the marker of the beginning of the anabolic when energy expenditure increases rapidly. This behavior of indirect calorimetry was observed in COVID-19 but has also been demonstrated in other patient populations.
Although indirect calorimetry can represent a reliable measure for determining the beginning of the anabolic phase, it is not a widely available measurement in ICUs, unlike urea and creatinine measurements that are part of routine daily exams in ICUs.
The urea/creatinine ratio may be an efficient catabolism marker to guide nutritional therapy in critically ill patients. Evidence to confirm this hypothesis can be obtained by comparing the urea/creatinine ratio with indirect calorimetry, which is the gold standard for evaluating energy expenditure and catabolism in these patients.
The primary objective will be to correlate the behavior of the urea/creatinine ratio with the energetic expenditure measured by indirect calorimetry in patients with severe forms of COVID-19 to identify the beginning of the anabolic phase that would be translated by a reduction in UCR and an increase in energy expenditure in IC. Secondarily, correlate other catabolism markers with calorimetry results. They are serum albumin, hemoglobin, and C-reactive protein.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Twenty critically ill COVID-19 patients admitted to a 35-bed ICU intended for patients with COVID-19 from April to August 2021 and who underwent determination of energy expenditure with indirect calorimetry on days 1, 4, 7, 9, 14, 17, and 20 days after admission, and who did not have serum creatinine > 4.0 mg/dL upon admission, were not chronic dialysis patients and did not undergo dialysis treatment during the study period. The urea, creatinine, C-reactive protein, hemoglobin, and albumin results will be obtained from the hospital's electronic medical record during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urea/creatinine ratio
Time frame: 30 days
Compare urea/creatinine ratio with indirect calorimetry to determine catabolism and optimize nutritional support in critically ill COVID-19 patients.
3 secondary outcomes
Serum albumin
Time frame: 30 days
Hemoglobin concentration
Time frame: 30 days
C-reactive protein
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Results publication: PubMed 37517372Singer P, Blaser AR, Berger MM, Calder PC, Casaer M, Hiesmayr M, Mayer K, Montejo-Gonzalez JC, Pichard C, Preiser JC, Szczeklik W, van Zanten ARH, Bischoff SC. ESPEN practical and partially revised guideline: Clinical nutrition in the intensive care unit. Clin Nutr. 2023 Sep;42(9):1671-1689. doi: 10.1016/j.clnu.2023.07.011. Epub 2023 Jul 15.
- Results publication: PubMed 3138511Long CL, Dillard DR, Bodzin JH, Geiger JW, Blakemore WS. Validity of 3-methylhistidine excretion as an indicator of skeletal muscle protein breakdown in humans. Metabolism. 1988 Sep;37(9):844-9. doi: 10.1016/0026-0495(88)90118-7.
- Results publication: PubMed 31531715Haines RW, Zolfaghari P, Wan Y, Pearse RM, Puthucheary Z, Prowle JR. Elevated urea-to-creatinine ratio provides a biochemical signature of muscle catabolism and persistent critical illness after major trauma. Intensive Care Med. 2019 Dec;45(12):1718-1731. doi: 10.1007/s00134-019-05760-5. Epub 2019 Sep 17.
- Results publication: PubMed 34620338Niederer LE, Miller H, Haines KL, Molinger J, Whittle J, MacLeod DB, McClave SA, Wischmeyer PE. Prolonged progressive hypermetabolism during COVID-19 hospitalization undetected by common predictive energy equations. Clin Nutr ESPEN. 2021 Oct;45:341-350. doi: 10.1016/j.clnesp.2021.07.021. Epub 2021 Aug 3.
- Results publication: PubMed 575168Long CL, Schaffel N, Geiger JW, Schiller WR, Blakemore WS. Metabolic response to injury and illness: estimation of energy and protein needs from indirect calorimetry and nitrogen balance. JPEN J Parenter Enteral Nutr. 1979 Nov-Dec;3(6):452-6. doi: 10.1177/014860717900300609.
- Results publication: PubMed 8633918Monk DN, Plank LD, Franch-Arcas G, Finn PJ, Streat SJ, Hill GL. Sequential changes in the metabolic response in critically injured patients during the first 25 days after blunt trauma. Ann Surg. 1996 Apr;223(4):395-405. doi: 10.1097/00000658-199604000-00008.
- Individual participant dataSharing planned: No
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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.
JOSE AZEVEDO, MD, PhD study director
Hospital São Domingos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by Hospital Sao Domingos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 19 Feb 2025. 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 Brazil. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urea/creatinine ratio (time frame: 30 days). 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 NCT06244381, which also lists 6 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 19 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.