Indirect Calorimetry Versus Urea-creatinine Ratio to Evaluate Catabolism in Critically Ill Patients

Critically Ill Clinical Trial

Official title:

NUTRITIONAL OPTIMIZATION IN THE DIFFERENT PHASES OF CRITICAL ILLNESS. Comparison of the Urea/Creatinine Ratio With Indirect Calorimetry.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06244381
• Other study ID #: hsd0124
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Hospital Sao Domingos
• Contact: JOSE AZEVEDO, MD, PhD
• Phone: +55 98 991375595
• Email: jrazevedo47[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 1, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Domingos

References & Publications (6)

Haines 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. — View Citation

Long 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. — View Citation

Long 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 — View Citation

Monk 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: 10.1097/00000658-199604000-000 — View Citation

Niederer 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. d — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urea/creatinine ratio	Compare urea/creatinine ratio with indirect calorimetry to determine catabolism and optimize nutritional support in critically ill COVID-19 patients.	30 days
Secondary	Serum albumin	Compare albumin with indirect calorimetry to determine catabolism and optimize nutritional support in critically ill COVID-19 patients.	30 days
Secondary	Hemoglobin concentration	Compare hemoglobin concentration with indirect calorimetry to determine catabolism and optimize nutritional support in critically ill COVID-19 patients.	30 days
Secondary	C-reactive protein	Compare C-reactive protein with indirect calorimetry to determine catabolism and optimize nutritional support in critically ill COVID-19 patients.	30 days