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Cardiopulmonary bypass (CPB) is crucial for surgical repair but is associated with systemic inflammation and\/or end-organ dysfunction. Ultrafiltration (UF) techniques, particularly zero-balance ultrafiltration (Z-BUF), have been developed to mitigate these effects by removing cytokines. Conventional hemofilters are widely used, but in low- and middle-income countries, high-flux hemodialyzers are increasingly substituted, although evidence for their equivalence in pediatric CPB remains scarce.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In this prospective, single-blinded, randomized controlled noninferiority trial, a total of 60 pediatric patients (aged 1\u201315 years) who underwent elective CPB for congenital heart surgery were enrolled. Thirty patients were assigned to the Medica hemofilter group, and thirty to the Fresenius Helixone\n                      <jats:sup>\u00ae<\/jats:sup>\n                      hemodialyzer group. Interleukin-6 (IL-6) was designated as the primary endpoint, whereas interleukin-1\u03b2 (IL-1\u03b2), hematocrit, lactate levels, mechanical ventilation (MV) duration, length of stay in the intensive care unit (ICU), and overall hospital stay served as secondary endpoints. Cytokine levels were measured at baseline (T1), before Z-BUF (T2), and immediately after Z-BUF (T3). Prespecified noninferiority margins were applied, and generalized estimating equations (GEEs) were used to assess temporal trends.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Baseline characteristics and procedural complexity were comparable between cohorts. Following Z-BUF, changes in IL-1\u03b2 (median difference\u2009\u2212\u20090.223 pg\/mL) and IL-6 (0.642 pg\/mL) met the predefined noninferiority criteria (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001 for both). GEE analysis revealed no significant interaction between filter type and cytokine trends. The median hematocrit, lactate levels, MV duration, length of stay in the ICU, and overall hospital stay were also similar between the study arms. Mortality was identical (3.3%) in both arms. Importantly, no cases of acute kidney injury or acute neurological events were observed in either group.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Compared with conventional hemofilters, high-flux hemodialyzers are noninferior in controlling intraoperative cytokines during Z-BUF in pediatric CPB and demonstrate comparable clinical safety outcomes. Hemodialyzers appear to be an effective and practical alternative in resource-limited settings. Validation in larger multicenter trials with extended postoperative sampling is warranted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration and date<\/jats:title>\n                    <jats:p>ClinicalTrials.gov (NCT06792565) on 22 March 2024.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13019-026-04058-0","type":"journal-article","created":{"date-parts":[[2026,4,13]],"date-time":"2026-04-13T15:37:50Z","timestamp":1776094670000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Hemofilters versus hemodialyzers: impacts on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery: a randomized controlled trial"],"prefix":"10.1186","volume":"21","author":[{"given":"Ahmed M.","family":"Abdelazim","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Basma","family":"Alaaeldin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akram M.","family":"Amer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amal","family":"Rizk","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dina","family":"Mahmoud","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasmin","family":"Elsobky","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hadeel","family":"Tawfik","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ahmed S.","family":"Fadaly","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mahmoud","family":"Elshazly","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2026,4,13]]},"reference":[{"key":"4058_CR1","doi-asserted-by":"publisher","first-page":"8895","DOI":"10.3390\/ijms25168895","volume":"25","author":"A Rangel-L\u00f3pez","year":"2024","unstructured":"Rangel-L\u00f3pez A, Gonz\u00e1lez-Cabello H, Paniagua-Medina ME, et al. 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Written informed consent was obtained from the parents\/ legal guardians prior to surgery. Patient confidentiality was strictly maintained in accordance with institutional policies, with all records coded and securely stored. Access to the data was restricted to the study team, and all investigators signed a confidentiality agreement.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"199"}}