Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patients
Introduction In patients on maintenance haemodialysis (HD), intradialytic hypotension (IDH) is a clinical problem that nephrologists and dialysis nurses face daily in their clinical routine. Despite the technological advances in the field of HD, the incidence of hypotensive events occurring during a...
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BMJ Publishing Group
2020-07-01
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| author | Paride Fenaroli Francesco Peyronel Elisabetta Parenti Giuseppe Daniele Benigno Giovanni Maria Rossi Umberto Maggiore Enrico Fiaccadori |
| author_facet | Paride Fenaroli Francesco Peyronel Elisabetta Parenti Giuseppe Daniele Benigno Giovanni Maria Rossi Umberto Maggiore Enrico Fiaccadori |
| author_sort | Paride Fenaroli |
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| description | Introduction In patients on maintenance haemodialysis (HD), intradialytic hypotension (IDH) is a clinical problem that nephrologists and dialysis nurses face daily in their clinical routine. Despite the technological advances in the field of HD, the incidence of hypotensive events occurring during a standard dialytic treatment is still very high. Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term. Various strategies aimed at preventing IDH are currently available, but there is lack of conclusive data on more integrated approaches combining different interventions.Methods and analysis This is a prospective, randomised, open-label, crossover trial (each subject will be used as his/her own control) that will be performed in two distinct phases, each of which is divided into several subphases. In the first phase, 27 HD sessions for each patient will be used, and will be aimed at the validation of a new ultrafiltration (UF) profile, designed with an ascending/descending shape, and a standard dialysate sodium concentration. In the second phase, 33 HD sessions for each patient will be used and will be aimed at evaluating the combination of different UF and sodium profiling strategies through individualised dialysate sodium concentration.Ethics and dissemination The trial protocol has been reviewed and approved by the local Institutional Ethics Committee (Comitato Etico AVEN, prot. 43391 22.10.19). The results of the trial will be presented at local and international conferences and submitted for publication to a peer-reviewed journal.Trial registration number ClinicalTrials.gov Registry (NCT03949088). |
| format | Article |
| id | doaj-art-7c4f31de75e2408ca5d55922a0f6c0c1 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-07-01 |
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| series | BMJ Open |
| spelling | doaj-art-7c4f31de75e2408ca5d55922a0f6c0c12024-12-05T05:10:11ZengBMJ Publishing GroupBMJ Open2044-60552020-07-0110710.1136/bmjopen-2020-036893Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patientsParide Fenaroli0Francesco Peyronel1Elisabetta Parenti2Giuseppe Daniele Benigno3Giovanni Maria Rossi4Umberto Maggiore5Enrico Fiaccadori6Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, ItalyScuola di Specializzazione in Nefrologia, Università degli Studi di Parma Dipartimento di Medicina e Chirurgia, Parma, Emilia-Romagna, ItalyUnità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, ItalyUnità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, ItalyUnità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, ItalyUnità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, ItalyUnità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, ItalyIntroduction In patients on maintenance haemodialysis (HD), intradialytic hypotension (IDH) is a clinical problem that nephrologists and dialysis nurses face daily in their clinical routine. Despite the technological advances in the field of HD, the incidence of hypotensive events occurring during a standard dialytic treatment is still very high. Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term. Various strategies aimed at preventing IDH are currently available, but there is lack of conclusive data on more integrated approaches combining different interventions.Methods and analysis This is a prospective, randomised, open-label, crossover trial (each subject will be used as his/her own control) that will be performed in two distinct phases, each of which is divided into several subphases. In the first phase, 27 HD sessions for each patient will be used, and will be aimed at the validation of a new ultrafiltration (UF) profile, designed with an ascending/descending shape, and a standard dialysate sodium concentration. In the second phase, 33 HD sessions for each patient will be used and will be aimed at evaluating the combination of different UF and sodium profiling strategies through individualised dialysate sodium concentration.Ethics and dissemination The trial protocol has been reviewed and approved by the local Institutional Ethics Committee (Comitato Etico AVEN, prot. 43391 22.10.19). The results of the trial will be presented at local and international conferences and submitted for publication to a peer-reviewed journal.Trial registration number ClinicalTrials.gov Registry (NCT03949088).https://bmjopen.bmj.com/content/10/7/e036893.full |
| spellingShingle | Paride Fenaroli Francesco Peyronel Elisabetta Parenti Giuseppe Daniele Benigno Giovanni Maria Rossi Umberto Maggiore Enrico Fiaccadori Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patients BMJ Open |
| title | Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patients |
| title_full | Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patients |
| title_fullStr | Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patients |
| title_full_unstemmed | Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patients |
| title_short | Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patients |
| title_sort | integrated strategies to prevent intradialytic hypotension research protocol of the dialhypot study a prospective randomised clinical trial in hypotension prone haemodialysis patients |
| url | https://bmjopen.bmj.com/content/10/7/e036893.full |
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