Renal InsufficiencyDIAMINONCT06659835
Amino Acid Loss During Continuous Renal Replacement Therapy
An observational study of Renal Insufficiency and Kidney Failure, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Kidney Failure
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 8 Feb 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Postoperative ICU patients
- Age ≥ 18 years
- Patients on enteral or/and parenteral nutrition given according to internal standard operating procedure
- CRRT group:
- CRRT treatment planned; all types of CRRT (continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemodiafiltration (CVVHDF), continuous veno-venous hemofiltration (CVVH))
- B)Non-CRRT group:
- no current or previous (<30 days) continuous or intermittent RRT
- no chronic kidney disease stage G3-G5
Who cannot join
- Preoperative intensive care patients
- Patients with liver cirrhosis stage 1-3 according to the Child-Pugh classification
- Patients with acute liver failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arabella Fischer, Dr. contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Sarah Yadavalli, Dr., +43 067761632558, sarah.yadavalli@meduniwien.ac.at
Arabella Fischer, Dr., arabella.fischer@meduniwien.ac.at
About this study
Official title: Amino Acid Effluent Loss During Continuous Renal Replacement Therapy: an Explorative Non-interventional Pilot Study
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.
Read the detailed description
In order to quantify the amount of amino acids lost via the continuous renal replacement (CRRT) machine, it is warranted to measure amino acid concentrations in the blood and effluent over the entire treatment period.
To this end, 20 intensive care patients will be examined throughout the entire duration of CRRT as part of this exploratory non-interventional study. Additionally, 10 intensive care patients without renal replacement therapy will be enrolled. In the CRRT-group amino acid loss through the effluent will be measured at different time points. Amino acid plasma concentrations will be determined in both groups. Amino acid urine concentration, nitrogen balance, as well as blood urea nitrogen, creatinine and albumin in the plasma will be measured as secondary outcome parameters. Additionally, observations regarding nutritional status and mobility (indirect calorimetry, bioimpedance analysis, ultrasound muscle and adipose tissue thickness, strength and mobility scoring) will be analyzed as exploratory secondary outcomes.
Duration of CRRT, length of intensive care and hospital stay as well as mortality will be monitored.
High-performance liquid chromatography fluorescence as well as liquid chromatography-mass spectrometry will be performed to measure amino acid concentrations in plasma, effluent and urine.
To answer the primary research question, change in amino acid plasma concentrations and effluent loss between treatment start and day 4 of continuous renal replacement therapy will be analysed using a two-sided Wilcoxon signed rank test.
- Conditions
- Renal Insufficiency, Kidney Failure
- Keywords
- amino acid, continuous renal replacement therapy, effluent loss
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRRT group | intensive care patients with continuous renal replacement therapy | |
| non-CRRT group | intensive care patients without renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino acid effluent loss
Change of effluent loss of amino acids from start of continuous renal replacement therapy to day 4
Measured: 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
Measured: 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
Measured: preoperative day/enrollment to postoperative day 4
Secondary outcomes (18)
Time course of effluent loss of amino acids over all measured time points
Time course of effluent loss of amino acids over all measured time points
Measured: duration of continuous renal replacement therapy, maximum 30 days
Time course of plasma concentration of amino acids over all measured time points
Time course of plasma concentration of amino acids over all measured time points
Measured: 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
Urine concentration of amino acids over treatment period
Measured: 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
Nitrogen balance over treatment period
Measured: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Blood urea nitrogen
Blood urea nitrogen over treatment period
Measured: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Creatinine
Creatinine in blood, effluent, urine over treatment period
Measured: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Albumin
Albumin in blood, effluent, urine over treatment period
Measured: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Total protein
Total protein in blood, effluent urine over treatment period
Measured: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Vitamins
Vitamins (Vitamin B12, folate) in blood, effluent, urine over treatment period
Measured: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Trace elements
Trace elements (iron, iodide) in blood, effluent, urine over treatment period
Measured: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Indirect Calorimetry
Indirect calorimetry over treatment period
Measured: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Bioimpedance analysis
Bioimpedance analysis over treatment period
Measured: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Ultrasound Muscle and Adipose Tissue Thickness
ultrasound to measure muscle and adipose tissue thickness over treatment period
Measured: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Muscle Strength
muscle strength assessment (Medical Research Council Scale for Muscle Strength) over treatment period
Measured: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Mobility
mobility assessment (Surgical Intensive Care Unit Optimal Mobilisation Score) over treatment period
Measured: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Duration of Continuous Renal Replacement Therapy
duration of Continuous Renal Replacement Therapy
Measured: duration of Continuous Renal Replacement Therapy (CRRT group), through study completion on average 10 days
Length of stay
Length of ICU stay
Measured: length of ICU and hospital stay, through study completion maximum 1 year
Mortality
mortality during ICU and hospital stay
Measured: length of ICU and hospital stay, through study completion maximum 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start8 Feb 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Arabella Fischer, MD, Medical University of Vienna
- Investigators
- Sarah Yadavalli, Dr., Principal investigator, Medical University of ViennaArabella Fischer, Dr., Principal investigator, Medical University of ViennaAndrea Laßnigg, Prof., Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659835
- Sponsor's protocol ID
- 2149/2023
- Acronym
- DIAMINO
- Status last verified
- May 2025
- First submitted
- 30 Jun 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 10809299Kihara 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.
PubMed 9037649Berger 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.
PubMed 15277163Stapel 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.
PubMed 31291614Story 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.
PubMed 9934919Sundstrom 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.
PubMed 29212550Bellomo 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.
PubMed 12027135Chua 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.
PubMed 35263692Fischer 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.
PubMed 26825278Kasotakis 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.
PubMed 22067629Jonckheer 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.
PubMed 30570180Oddoye 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.
PubMed 430238Bernardi 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.
PubMed 26801479
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acid Effluent Loss During Continuous Renal Replacement Therapy: an Explorative Non-interventional Pilot Study
- ClinicalTrials.gov ID
- NCT06659835
- Acronym / sponsor ID
- DIAMINO / 2149/2023
- Conditions
- Renal Insufficiency, Kidney Failure
- Keywords
- amino acid, continuous renal replacement therapy, effluent loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Oct 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.
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.
Detailed description
In order to quantify the amount of amino acids lost via the continuous renal replacement (CRRT) machine, it is warranted to measure amino acid concentrations in the blood and effluent over the entire treatment period.
To this end, 20 intensive care patients will be examined throughout the entire duration of CRRT as part of this exploratory non-interventional study. Additionally, 10 intensive care patients without renal replacement therapy will be enrolled. In the CRRT-group amino acid loss through the effluent will be measured at different time points. Amino acid plasma concentrations will be determined in both groups. Amino acid urine concentration, nitrogen balance, as well as blood urea nitrogen, creatinine and albumin in the plasma will be measured as secondary outcome parameters. Additionally, observations regarding nutritional status and mobility (indirect calorimetry, bioimpedance analysis, ultrasound muscle and adipose tissue thickness, strength and mobility scoring) will be analyzed as exploratory secondary outcomes.
Duration of CRRT, length of intensive care and hospital stay as well as mortality will be monitored.
High-performance liquid chromatography fluorescence as well as liquid chromatography-mass spectrometry will be performed to measure amino acid concentrations in plasma, effluent and urine.
To answer the primary research question, change in amino acid plasma concentrations and effluent loss between treatment start and day 4 of continuous renal replacement therapy will be analysed using a two-sided Wilcoxon signed rank test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRRT group | – | –intensive care patients with continuous renal replacement therapy |
| non-CRRT group | – | –intensive care patients without renal replacement therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Postoperative ICU patients
- Age ≥ 18 years
- Patients on enteral or/and parenteral nutrition given according to internal standard operating procedure
- CRRT group:
- CRRT treatment planned; all types of CRRT (continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemodiafiltration (CVVHDF), continuous veno-venous hemofiltration (CVVH))
Key exclusion criteria (3 listed)
- Preoperative intensive care patients
- Patients with liver cirrhosis stage 1-3 according to the Child-Pugh classification
- Patients with acute liver failure
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
Amino acid effluent loss
Time frame: CRRT start, day 4 of continuous renal replacement therapy
Change of effluent loss of amino acids from start of continuous renal replacement therapy to day 4
Amino acid plasma concentration CRRT group
Time frame: day 0, day 4 of continuous renal replacement therapy
Change of plasma concentration of amino acids from start of continuous renal replacement therapy to day 4
Amino acid plasma concentration non-CRRT group
Time frame: preoperative day/enrollment to postoperative day 4
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
18 secondary outcomes
Time course of effluent loss of amino acids over all measured time points
Time frame: duration of continuous renal replacement therapy, maximum 30 days
Time course of plasma concentration of amino acids over all measured time points
Time frame: 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
Time frame: 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
Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Blood urea nitrogen
Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Creatinine
Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Albumin
Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Total protein
Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Vitamins
Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Trace elements
Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Indirect Calorimetry
Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Bioimpedance analysis
Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Ultrasound Muscle and Adipose Tissue Thickness
Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Muscle Strength
Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Mobility
Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
Duration of Continuous Renal Replacement Therapy
Time frame: duration of Continuous Renal Replacement Therapy (CRRT group), through study completion on average 10 days
Length of stay
Time frame: length of ICU and hospital stay, through study completion maximum 1 year
Mortality
Time frame: length of ICU and hospital stay, through study completion maximum 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 10809299Maxvold 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.
- Background: PubMed 9037649Kihara 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.
- Background: PubMed 15277163Berger 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.
- Background: PubMed 31291614Stapel 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.
- Background: PubMed 9934919Story 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.
- Background: PubMed 29212550Sundstrom 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.
- Background: PubMed 12027135Bellomo 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.
- BackgroundChua 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
- Background: PubMed 35263692Fischer 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.
- Background: PubMed 26825278Fischer 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.
- Background: PubMed 22067629Kasotakis 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.
- Background: PubMed 30570180Jonckheer 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.
- Individual participant dataSharing planned: Undecided
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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.
Arabella Fischer, Dr. contact
Sarah Yadavalli, Dr. principal investigator
Medical University of Vienna
Arabella Fischer, Dr. principal investigator
Medical University of Vienna
Andrea Laßnigg, Prof. study director
Medical University of Vienna
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 Renal Insufficiency and Kidney Failure, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 25 May 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Yadavalli, Dr. (+43 67761632558, sarah.yadavalli@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amino acid effluent loss (time frame: CRRT start, day 4 of continuous renal replacement therapy). The study lists 3 primary outcomes in all. 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 NCT06659835, which also lists 14 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 25 May 2025.