NCT06244381 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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
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
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
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.

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

Clinical trial NCT06244381 - References