Paul Köglberger, Fabian Perschinka, Sebastian J Klein, Timo Mayerhöfer, Sarah Maier, Hanno Ulmer, Romuald Bellmann, Michael Joannidis
{"title":"CVVH与RCA期间两种不同碳酸氢盐替代液的比较方案：一项前瞻性、随机、对照试验。","authors":"Paul Köglberger, Fabian Perschinka, Sebastian J Klein, Timo Mayerhöfer, Sarah Maier, Hanno Ulmer, Romuald Bellmann, Michael Joannidis","doi":"10.1159/000547401","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Acid-base disturbances are common issues during continuous veno-venous hemofiltration (CVVH). Especially using regional citrate anticoagulation (RCA), recent studies have shown that control in intracorporal pH and HCO<sub>3</sub> concentration may be improved when the replacement fluid is changed to a solution with a lower <inline-formula><mml:math id=\"m1\" xmlns:mml=\"http://www.w3.org/1998/Math/MathML\"><mml:mrow><mml:msubsup><mml:mtext>HCO</mml:mtext><mml:mn>3</mml:mn><mml:mo>-</mml:mo></mml:msubsup></mml:mrow></mml:math></inline-formula> concentration during continuous renal replacement therapy. This prospective trail aimed to compare acid-base balance between a high (HBF) and low (LBF) bicarbonate replacement fluid over a period of 96 h after CVVH initiation using RCA.</p><p><strong>Methods: </strong>This is a prospective, randomized, controlled, open-label, crossover, phase II, single-center study involving critically ill patients requiring RRT. The two replacement fluids (Phoxilium and Biphozyl) are compared in two groups with 1:1 block randomization and consecutive crossover after 48 h of CVVH. The primary endpoints are the occurrence of at least one pH (>7.45) or <inline-formula><mml:math id=\"m2\" xmlns:mml=\"http://www.w3.org/1998/Math/MathML\"><mml:mrow><mml:msubsup><mml:mtext>HCO</mml:mtext><mml:mn>3</mml:mn><mml:mo>-</mml:mo></mml:msubsup></mml:mrow></mml:math></inline-formula> (>26 mmol/L) excursion within 16-48 h of each treatment phase using a generalized estimating equation approach. The objective was to examine differences of pH and <inline-formula><mml:math id=\"m3\" xmlns:mml=\"http://www.w3.org/1998/Math/MathML\"><mml:mrow><mml:msubsup><mml:mtext>HCO</mml:mtext><mml:mn>3</mml:mn><mml:mo>-</mml:mo></mml:msubsup></mml:mrow></mml:math></inline-formula> between patients who receive LBF and HBF as replacement fluid during CVVH. We hypothesize that during CVVH with LBF, pH, and HCO<sub>3</sub>- excursion rates are significantly lower compared to HBF. Recruitment of 88 study participants is ongoing, with the trial expected to be completed in 2025. Data cleaning, analysis, and publication preparation will follow thereafter. The trial is registered at <ext-link ext-link-type=\"uri\" xlink:href=\"http://ClinicalTrials.gov\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">ClinicalTrials.gov</ext-link> (NCT04071171) and EudraCT (2019-001262-15).</p><p><strong>Conclusion: </strong>Given the broad inclusion and restricted exclusion criteria, we expect the results of the BiPhox-Trial to be broadly applicable to patients in need of CVVH with RCA in the intensive care setting. This trial aims to determine whether the use of LBF results in more stable acid-base parameters compared to HBF during CVVH with RCA in critically ill patients and may guide therapeutic decisions in clinical practice.</p>","PeriodicalId":8953,"journal":{"name":"Blood Purification","volume":" ","pages":"1-10"},"PeriodicalIF":1.8000,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Protocol of the Comparison of Two Different Bicarbonate Replacement Fluids during Continuous Veno-Venous Hemofiltration with Regional Citrate Anticoagulation: A Prospective, Randomized, Controlled Trial.\",\"authors\":\"Paul Köglberger, Fabian Perschinka, Sebastian J Klein, Timo Mayerhöfer, Sarah Maier, Hanno Ulmer, Romuald Bellmann, Michael Joannidis\",\"doi\":\"10.1159/000547401\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Acid-base disturbances are common issues during continuous veno-venous hemofiltration (CVVH). Especially using regional citrate anticoagulation (RCA), recent studies have shown that control in intracorporal pH and HCO<sub>3</sub> concentration may be improved when the replacement fluid is changed to a solution with a lower <inline-formula><mml:math id=\\\"m1\\\" xmlns:mml=\\\"http://www.w3.org/1998/Math/MathML\\\"><mml:mrow><mml:msubsup><mml:mtext>HCO</mml:mtext><mml:mn>3</mml:mn><mml:mo>-</mml:mo></mml:msubsup></mml:mrow></mml:math></inline-formula> concentration during continuous renal replacement therapy. This prospective trail aimed to compare acid-base balance between a high (HBF) and low (LBF) bicarbonate replacement fluid over a period of 96 h after CVVH initiation using RCA.</p><p><strong>Methods: </strong>This is a prospective, randomized, controlled, open-label, crossover, phase II, single-center study involving critically ill patients requiring RRT. The two replacement fluids (Phoxilium and Biphozyl) are compared in two groups with 1:1 block randomization and consecutive crossover after 48 h of CVVH. The primary endpoints are the occurrence of at least one pH (>7.45) or <inline-formula><mml:math id=\\\"m2\\\" xmlns:mml=\\\"http://www.w3.org/1998/Math/MathML\\\"><mml:mrow><mml:msubsup><mml:mtext>HCO</mml:mtext><mml:mn>3</mml:mn><mml:mo>-</mml:mo></mml:msubsup></mml:mrow></mml:math></inline-formula> (>26 mmol/L) excursion within 16-48 h of each treatment phase using a generalized estimating equation approach. The objective was to examine differences of pH and <inline-formula><mml:math id=\\\"m3\\\" xmlns:mml=\\\"http://www.w3.org/1998/Math/MathML\\\"><mml:mrow><mml:msubsup><mml:mtext>HCO</mml:mtext><mml:mn>3</mml:mn><mml:mo>-</mml:mo></mml:msubsup></mml:mrow></mml:math></inline-formula> between patients who receive LBF and HBF as replacement fluid during CVVH. We hypothesize that during CVVH with LBF, pH, and HCO<sub>3</sub>- excursion rates are significantly lower compared to HBF. Recruitment of 88 study participants is ongoing, with the trial expected to be completed in 2025. Data cleaning, analysis, and publication preparation will follow thereafter. The trial is registered at <ext-link ext-link-type=\\\"uri\\\" xlink:href=\\\"http://ClinicalTrials.gov\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\">ClinicalTrials.gov</ext-link> (NCT04071171) and EudraCT (2019-001262-15).</p><p><strong>Conclusion: </strong>Given the broad inclusion and restricted exclusion criteria, we expect the results of the BiPhox-Trial to be broadly applicable to patients in need of CVVH with RCA in the intensive care setting. This trial aims to determine whether the use of LBF results in more stable acid-base parameters compared to HBF during CVVH with RCA in critically ill patients and may guide therapeutic decisions in clinical practice.</p>\",\"PeriodicalId\":8953,\"journal\":{\"name\":\"Blood Purification\",\"volume\":\" \",\"pages\":\"1-10\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2025-08-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Blood Purification\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000547401\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Blood Purification","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000547401","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEMATOLOGY","Score":null,"Total":0}
Protocol of the Comparison of Two Different Bicarbonate Replacement Fluids during Continuous Veno-Venous Hemofiltration with Regional Citrate Anticoagulation: A Prospective, Randomized, Controlled Trial.
Introduction: Acid-base disturbances are common issues during continuous veno-venous hemofiltration (CVVH). Especially using regional citrate anticoagulation (RCA), recent studies have shown that control in intracorporal pH and HCO3 concentration may be improved when the replacement fluid is changed to a solution with a lower HCO3- concentration during continuous renal replacement therapy. This prospective trail aimed to compare acid-base balance between a high (HBF) and low (LBF) bicarbonate replacement fluid over a period of 96 h after CVVH initiation using RCA.
Methods: This is a prospective, randomized, controlled, open-label, crossover, phase II, single-center study involving critically ill patients requiring RRT. The two replacement fluids (Phoxilium and Biphozyl) are compared in two groups with 1:1 block randomization and consecutive crossover after 48 h of CVVH. The primary endpoints are the occurrence of at least one pH (>7.45) or HCO3- (>26 mmol/L) excursion within 16-48 h of each treatment phase using a generalized estimating equation approach. The objective was to examine differences of pH and HCO3- between patients who receive LBF and HBF as replacement fluid during CVVH. We hypothesize that during CVVH with LBF, pH, and HCO3- excursion rates are significantly lower compared to HBF. Recruitment of 88 study participants is ongoing, with the trial expected to be completed in 2025. Data cleaning, analysis, and publication preparation will follow thereafter. The trial is registered at ClinicalTrials.gov (NCT04071171) and EudraCT (2019-001262-15).
Conclusion: Given the broad inclusion and restricted exclusion criteria, we expect the results of the BiPhox-Trial to be broadly applicable to patients in need of CVVH with RCA in the intensive care setting. This trial aims to determine whether the use of LBF results in more stable acid-base parameters compared to HBF during CVVH with RCA in critically ill patients and may guide therapeutic decisions in clinical practice.
期刊介绍：
Practical information on hemodialysis, hemofiltration, peritoneal dialysis and apheresis is featured in this journal. Recognizing the critical importance of equipment and procedures, particular emphasis has been placed on reports, drawn from a wide range of fields, describing technical advances and improvements in methodology. Papers reflect the search for cost-effective solutions which increase not only patient survival but also patient comfort and disease improvement through prevention or correction of undesirable effects. Advances in vascular access and blood anticoagulation, problems associated with exposure of blood to foreign surfaces and acute-care nephrology, including continuous therapies, also receive attention. Nephrologists, internists, intensivists and hospital staff involved in dialysis, apheresis and immunoadsorption for acute and chronic solid organ failure will find this journal useful and informative. ''Blood Purification'' also serves as a platform for multidisciplinary experiences involving nephrologists, cardiologists and critical care physicians in order to expand the level of interaction between different disciplines and specialities.
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