Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT06659835
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2024-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amino Acid Loss During Continuous Renal Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma, serum, urine, effluent'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2024-06-30', 'studyFirstSubmitQcDate': '2024-10-24', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amino acid effluent loss', 'timeFrame': 'CRRT start, day 4 of continuous renal replacement therapy', 'description': 'Change of effluent loss of amino acids from start of continuous renal replacement therapy to day 4'}, {'measure': 'Amino acid plasma concentration CRRT group', 'timeFrame': 'day 0, day 4 of continuous renal replacement therapy', 'description': 'Change of plasma concentration of amino acids from start of continuous renal replacement therapy to day 4'}, {'measure': 'Amino acid plasma concentration non-CRRT group', 'timeFrame': 'preoperative day/enrollment to postoperative day 4', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Time course of effluent loss of amino acids over all measured time points', 'timeFrame': 'duration of continuous renal replacement therapy, maximum 30 days', 'description': 'Time course of effluent loss of amino acids over all measured time points'}, {'measure': 'Time course of plasma concentration of amino acids over all measured time points', 'timeFrame': 'preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'Time course of plasma concentration of amino acids over all measured time points'}, {'measure': 'Urine concentration of amino acids over treatment period', 'timeFrame': 'preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'Urine concentration of amino acids over treatment period'}, {'measure': 'Nitrogen balance', 'timeFrame': 'duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'Nitrogen balance over treatment period'}, {'measure': 'Blood urea nitrogen', 'timeFrame': 'preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'Blood urea nitrogen over treatment period'}, {'measure': 'Creatinine', 'timeFrame': 'preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'Creatinine in blood, effluent, urine over treatment period'}, {'measure': 'Albumin', 'timeFrame': 'preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'Albumin in blood, effluent, urine over treatment period'}, {'measure': 'Total protein', 'timeFrame': 'preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'Total protein in blood, effluent urine over treatment period'}, {'measure': 'Vitamins', 'timeFrame': 'duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'Vitamins (Vitamin B12, folate) in blood, effluent, urine over treatment period'}, {'measure': 'Trace elements', 'timeFrame': 'duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'Trace elements (iron, iodide) in blood, effluent, urine over treatment period'}, {'measure': 'Indirect Calorimetry', 'timeFrame': 'duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'Indirect calorimetry over treatment period'}, {'measure': 'Bioimpedance analysis', 'timeFrame': 'preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'Bioimpedance analysis over treatment period'}, {'measure': 'Ultrasound Muscle and Adipose Tissue Thickness', 'timeFrame': 'preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'ultrasound to measure muscle and adipose tissue thickness over treatment period'}, {'measure': 'Muscle Strength', 'timeFrame': 'duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'muscle strength assessment (Medical Research Council Scale for Muscle Strength) over treatment period'}, {'measure': 'Mobility', 'timeFrame': 'duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days', 'description': 'mobility assessment (Surgical Intensive Care Unit Optimal Mobilisation Score) over treatment period'}, {'measure': 'Duration of Continuous Renal Replacement Therapy', 'timeFrame': 'duration of Continuous Renal Replacement Therapy (CRRT group), through study completion on average 10 days', 'description': 'duration of Continuous Renal Replacement Therapy'}, {'measure': 'Length of stay', 'timeFrame': 'length of ICU and hospital stay, through study completion maximum 1 year', 'description': 'Length of ICU stay'}, {'measure': 'Mortality', 'timeFrame': 'length of ICU and hospital stay, through study completion maximum 1 year', 'description': 'mortality during ICU and hospital stay'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['amino acid', 'continuous renal replacement therapy', 'effluent loss'], 'conditions': ['Renal Insufficiency', 'Kidney Failure']}, 'referencesModule': {'references': [{'pmid': '10809299', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9037649', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15277163', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31291614', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9934919', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29212550', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12027135', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '35263692', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26825278', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22067629', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30570180', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '430238', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26801479', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\nWhat 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?\n\nAmino 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.', 'detailedDescription': '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.\n\nTo 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.\n\nDuration of CRRT, length of intensive care and hospital stay as well as mortality will be monitored.\n\nHigh-performance liquid chromatography fluorescence as well as liquid chromatography-mass spectrometry will be performed to measure amino acid concentrations in plasma, effluent and urine.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Postoperative ICU patients\n* Age ≥ 18 years\n* Patients on enteral or/and parenteral nutrition given according to internal standard operating procedure\n\nA) CRRT group:\n\n\\- CRRT treatment planned; all types of CRRT (continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemodiafiltration (CVVHDF), continuous veno-venous hemofiltration (CVVH))\n\nB)Non-CRRT group:\n\n* no current or previous (\\<30 days) continuous or intermittent RRT\n* no chronic kidney disease stage G3-G5\n\nExclusion criteria:\n\n* Preoperative intensive care patients\n* Patients with liver cirrhosis stage 1-3 according to the Child-Pugh classification\n* Patients with acute liver failure'}, 'identificationModule': {'nctId': 'NCT06659835', 'acronym': 'DIAMINO', 'briefTitle': 'Amino Acid Loss During Continuous Renal Replacement Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Amino Acid Effluent Loss During Continuous Renal Replacement Therapy: an Explorative Non-interventional Pilot Study', 'orgStudyIdInfo': {'id': '2149/2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CRRT group', 'description': 'intensive care patients with continuous renal replacement therapy'}, {'label': 'non-CRRT group', 'description': 'intensive care patients without renal replacement therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Sarah Yadavalli, Dr.', 'role': 'CONTACT', 'email': 'sarah.yadavalli@meduniwien.ac.at', 'phone': '+43 067761632558'}, {'name': 'Arabella Fischer, Dr.', 'role': 'CONTACT', 'email': 'arabella.fischer@meduniwien.ac.at'}, {'name': 'Arabella Fischer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Sarah Yadavalli, Dr.', 'role': 'CONTACT', 'email': 'sarah.yadavalli@meduniwien.ac.at', 'phone': '+43 67761632558'}, {'name': 'Arabella Fischer, Dr.', 'role': 'CONTACT', 'email': 'arabella.fischer@meduniwien.ac.at'}], 'overallOfficials': [{'name': 'Sarah Yadavalli, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}, {'name': 'Arabella Fischer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}, {'name': 'Andrea Laßnigg, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Arabella Fischer, MD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}