NCT06659835|Recruiting
Amino Acid Loss During Continuous Renal Replacement Therapy
DIAMINO
Amino Acid Effluent Loss During Continuous Renal Replacement Therapy: an Explorative Non-interventional Pilot Study
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DIAMINO
Amino Acid Effluent Loss During Continuous Renal Replacement Therapy: an Explorative Non-interventional Pilot Study
Sponsor study identifier
observational
30
1 country
1
Study Start
February 8, 2025
Actual (reported)Primary Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this observational study is to learn about amino acid loss during continuous renal replacement therapy and plasma amino acid levels in intensive care patients. The main questions it aims to answer are: What amount of amino acids is lost over the duration of continuous renal replacement therapy? How do amino acid plasma concentrations change over time in patients with and without continuous renal replacement therapy? Amino acid concentrations will be measured in the effluent and in the plasma of patients receiving continuous renal replacement therapy as part of their regular medical care. In addition, plasma concentrations of amino acids will be studied in patients without renal replacement therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 30, 2024
Actual (reported)October 26, 2024
Actual (reported)February 8, 2025
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Amino acid effluent loss
Change of effluent loss of amino acids from start of continuous renal replacement therapy to day 4
CRRT start, day 4 of continuous renal replacement therapy
Amino acid plasma concentration CRRT group
Change of plasma concentration of amino acids from start of continuous renal replacement therapy to day 4
day 0, day 4 of continuous renal replacement therapy
Amino acid plasma concentration non-CRRT group
Change of plasma concentration of amino acids from the preoperative day to postoperative day 4 or to the last measurement at the intensive care unit, whichever is earlier
preoperative day/enrollment to postoperative day 4
Time course of effluent loss of amino acids over all measured time points
duration of continuous renal replacement therapy, maximum 30 days
Time course of plasma concentration of amino acids over all measured time points
preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Urine concentration of amino acids over treatment period
preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Nitrogen balance
duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Blood urea nitrogen
preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
intensive care patients with continuous renal replacement therapy
intensive care patients without renal replacement therapy
This study will enroll 30 intensive care patients: 20 patients receiving continuous renal replacement therapy and 10 patients without renal replacement therapy. The study will be carried out at the Medical University of Vienna at a 16-bed intensive care unit admitting patients after cardiothoracic and major vascular surgery.
Medical University of Vienna
Vienna, State of Vienna, 1090, Austria
Maxvold NJ, Smoyer WE, Custer JR, Bunchman TE. Amino acid loss and nitrogen balance in critically ill children with acute renal failure: a prospective comparison between classic hemofiltration and hemofiltration with dialysis. Crit Care Med. 2000 Apr;28(4):1161-5. doi: 10.1097/00003246-200004000-00041.
Kihara M, Ikeda Y, Fujita H, Miura M, Masumori S, Tamura K, Yabana M, Takagi N, Umemura S, Ishii M. Amino acid losses and nitrogen balance during slow diurnal hemodialysis in critically ill patients with renal failure. Intensive Care Med. 1997 Jan;23(1):110-3. doi: 10.1007/s001340050299.
plasma, serum, urine, effluent
Sarah Yadavalli, Dr.
Medical University of Vienna
Arabella Fischer, Dr.
Medical University of Vienna
Andrea Laßnigg, Prof.
Medical University of Vienna
First Submitted
June 30, 2024
First Posted
October 26, 2024
Study Start
February 8, 2025
Actual (reported)Primary Completion
September 2026
Estimated (date passed)Phase 1 Renal Insufficiency Trial of Methoxyethyl Etomidate Hydrochloride
Contact the study team to confirm eligibility.
Berger MM, Shenkin A, Revelly JP, Roberts E, Cayeux MC, Baines M, Chiolero RL. Copper, selenium, zinc, and thiamine balances during continuous venovenous hemodiafiltration in critically ill patients. Am J Clin Nutr. 2004 Aug;80(2):410-6. doi: 10.1093/ajcn/80.2.410.
Stapel SN, de Boer RJ, Thoral PJ, Vervloet MG, Girbes ARJ, Oudemans-van Straaten HM. Amino Acid Loss during Continuous Venovenous Hemofiltration in Critically Ill Patients. Blood Purif. 2019;48(4):321-329. doi: 10.1159/000500998. Epub 2019 Jul 10.
Story DA, Ronco C, Bellomo R. Trace element and vitamin concentrations and losses in critically ill patients treated with continuous venovenous hemofiltration. Crit Care Med. 1999 Jan;27(1):220-3. doi: 10.1097/00003246-199901000-00057.
Sundstrom Rehal M, Liebau F, Tjader I, Norberg A, Rooyackers O, Wernerman J. A supplemental intravenous amino acid infusion sustains a positive protein balance for 24 hours in critically ill patients. Crit Care. 2017 Dec 6;21(1):298. doi: 10.1186/s13054-017-1892-x.
Bellomo R, Tan HK, Bhonagiri S, Gopal I, Seacombe J, Daskalakis M, Boyce N. High protein intake during continuous hemodiafiltration: impact on amino acids and nitrogen balance. Int J Artif Organs. 2002 Apr;25(4):261-8. doi: 10.1177/039139880202500403.
Chua HR, Bellomo R. Nutritional Management of Patients Treated with Continuous Renal Replacement Therapy. Elsevier Inc.; 2013. https://doi.org/10.1016/B978-0-12-391934-2.00037-0
Fischer A, Hertwig A, Hahn R, Anwar M, Siebenrock T, Pesta M, Liebau K, Timmermann I, Brugger J, Posch M, Ringl H, Tamandl D, Hiesmayr M; USVALID Collaboration Group. Validation of bedside ultrasound to predict lumbar muscle area in the computed tomography in 200 non-critically ill patients: The USVALID prospective study. Clin Nutr. 2022 Apr;41(4):829-837. doi: 10.1016/j.clnu.2022.01.034. Epub 2022 Feb 11.
Fischer A, Spiegl M, Altmann K, Winkler A, Salamon A, Themessl-Huber M, Mouhieddine M, Strasser EM, Schiferer A, Paternostro-Sluga T, Hiesmayr M. Muscle mass, strength and functional outcomes in critically ill patients after cardiothoracic surgery: does neuromuscular electrical stimulation help? The Catastim 2 randomized controlled trial. Crit Care. 2016 Jan 29;20:30. doi: 10.1186/s13054-016-1199-3.
Kasotakis G, Schmidt U, Perry D, Grosse-Sundrup M, Benjamin J, Ryan C, Tully S, Hirschberg R, Waak K, Velmahos G, Bittner EA, Zafonte R, Cobb JP, Eikermann M. The surgical intensive care unit optimal mobility score predicts mortality and length of stay. Crit Care Med. 2012 Apr;40(4):1122-8. doi: 10.1097/CCM.0b013e3182376e6d.
Jonckheer J, Vergaelen K, Spapen H, Malbrain MLNG, De Waele E. Modification of Nutrition Therapy During Continuous Renal Replacement Therapy in Critically Ill Pediatric Patients: A Narrative Review and Recommendations. Nutr Clin Pract. 2019 Feb;34(1):37-47. doi: 10.1002/ncp.10231. Epub 2018 Dec 20.
Oddoye EA, Margen S. Nitrogen balance studies in humans: long-term effect of high nitrogen intake on nitrogen accretion. J Nutr. 1979 Mar;109(3):363-77. doi: 10.1093/jn/109.3.363.
Bernardi MH, Schmidlin D, Ristl R, Heitzinger C, Schiferer A, Neugebauer T, Wrba T, Hiesmayr M, Druml W, Lassnigg A. Serum Creatinine Back-Estimation in Cardiac Surgery Patients: Misclassification of AKI Using Existing Formulae and a Data-Driven Model. Clin J Am Soc Nephrol. 2016 Mar 7;11(3):395-404. doi: 10.2215/CJN.03560315. Epub 2016 Jan 22.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 25, 2025
Record last verified: 2025-05
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