Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial
Introduction Current evidence on vascular access strategies for haemodialysis patients is based on observational studies that are at high risk of selection bias. For elderly patients, autologous arteriovenous fistulas that are typically created in usual care may not be the best option because a sign...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-02-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/2/e053108.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1823858062753005568 |
|---|---|
| author | Patrick WHE Vriens Edith M Willigendael Maarten A Lijkwan Friedo W Dekker Chava L Ramspek Michiel W de Haan Çaĝdaş Ünlü Boudewijn DC Heggen Koen E A van der Bogt Marc H Hemmelder Mickaël J C Hiligsmann Magda M van Loon Joris I Rotmans Jan H M Tordoir Geert Willem H Schurink Maarten G J Snoeijs Marijke J Molegraaf Philippe WM Cuypers Denise Nio Cora H Arts Jacobien C Verhave Goos D Laverman Aron S Bode Marcel C Weijmer Bas Govaert Aaltje Y Adema Gijs MJM Welten Michel MPJ Reijnen Marc JH Groeneveld Hans S Brink Jeroen B van der Net Arno Kuijper Hilde PE Peters Roos C van Nieuwenhuizen Rombout R Kruse Yvonne C Schrama Karina A de Groot Karima Farhat |
| author_facet | Patrick WHE Vriens Edith M Willigendael Maarten A Lijkwan Friedo W Dekker Chava L Ramspek Michiel W de Haan Çaĝdaş Ünlü Boudewijn DC Heggen Koen E A van der Bogt Marc H Hemmelder Mickaël J C Hiligsmann Magda M van Loon Joris I Rotmans Jan H M Tordoir Geert Willem H Schurink Maarten G J Snoeijs Marijke J Molegraaf Philippe WM Cuypers Denise Nio Cora H Arts Jacobien C Verhave Goos D Laverman Aron S Bode Marcel C Weijmer Bas Govaert Aaltje Y Adema Gijs MJM Welten Michel MPJ Reijnen Marc JH Groeneveld Hans S Brink Jeroen B van der Net Arno Kuijper Hilde PE Peters Roos C van Nieuwenhuizen Rombout R Kruse Yvonne C Schrama Karina A de Groot Karima Farhat |
| collection | DOAJ |
| description | Introduction Current evidence on vascular access strategies for haemodialysis patients is based on observational studies that are at high risk of selection bias. For elderly patients, autologous arteriovenous fistulas that are typically created in usual care may not be the best option because a significant proportion of fistulas either fail to mature or remain unused. In addition, long-term complications associated with arteriovenous grafts and central venous catheters may be less relevant when considering the limited life expectancy of these patients. Therefore, we designed the Optimising Access Surgery in Senior Haemodialysis Patients (OASIS) trial to determine the best strategy for vascular access creation in elderly haemodialysis patients.Methods and analysis OASIS is a multicentre randomised controlled trial with an equal participant allocation in three treatment arms. Patients aged 70 years or older who are expected to initiate haemodialysis treatment in the next 6 months or who have started haemodialysis urgently with a catheter will be enrolled. To detect and exclude patients with an unusually long life expectancy, we will use a previously published mortality prediction model after external validation. Participants allocated to the usual care arm will be treated according to current guidelines on vascular access creation and will undergo fistula creation. Participants allocated to one of the two intervention arms will undergo graft placement or catheter insertion. The primary outcome is the number of access-related interventions required for each patient-year of haemodialysis treatment. We will enrol 195 patients to have sufficient statistical power to detect an absolute decrease of 0.80 interventions per year.Ethics and dissemination Because of clinical equipoise, we believe it is justified to randomly allocate elderly patients to the different vascular access strategies. The study was approved by an accredited medical ethics review committee. The results will be disseminated through peer-reviewed publications and will be implemented in clinical practice guidelines.Trial registration number NL7933.Protocol version and date V.5, 25 February 2021. |
| format | Article |
| id | doaj-art-902335e474734d7ebf31422a0cf064f7 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-902335e474734d7ebf31422a0cf064f72025-02-11T16:20:13ZengBMJ Publishing GroupBMJ Open2044-60552022-02-0112210.1136/bmjopen-2021-053108Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial 0Patrick WHE VriensEdith M WilligendaelMaarten A LijkwanFriedo W Dekker1Chava L Ramspek2Michiel W de Haan3Çaĝdaş Ünlü4Boudewijn DC Heggen5Koen E A van der Bogt6Marc H Hemmelder7Mickaël J C Hiligsmann8Magda M van Loon9Joris I Rotmans10Jan H M Tordoir11Geert Willem H Schurink12Maarten G J Snoeijs13Marijke J MolegraafPhilippe WM CuypersDenise NioCora H ArtsJacobien C VerhaveGoos D LavermanAron S BodeMarcel C WeijmerBas GovaertAaltje Y AdemaGijs MJM WeltenMichel MPJ ReijnenMarc JH GroeneveldHans S BrinkJeroen B van der NetArno KuijperHilde PE PetersRoos C van NieuwenhuizenRombout R KruseYvonne C SchramaKarina A de GrootKarima FarhatKenya National Bureau of Statistics, Nairobi, Nairobi, Kenyaprofessor of clinical epidemiologyDepartment of Clinical Epidemiology, Leiden University Medical Centre, Leiden, NetherlandsDepartment of Radiology, Maastricht University Medical Centre+, Maastricht, NetherlandsSurgery, Noordwest Ziekenhuisgroep, Alkmaar, NetherlandsDepartment of Vascular Surgery, Maastricht University Medical Centre+, Maastricht, NetherlandsDepartment of Surgery, Haaglanden Medical Centre, The Hague, NetherlandsDepartment of Internal Medicine, Division of Nephrology, Maastricht University Medical Centre+, Maastricht, NetherlandsDepartment of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, NetherlandsDepartment of Vascular Surgery, Maastricht University Medical Centre+, Maastricht, NetherlandsDepartment of Internal Medicine, Leiden University Medical Centre, Leiden, NetherlandsDepartment of Vascular Surgery, Maastricht University Medical Centre+, Maastricht, NetherlandsDepartment of Vascular Surgery, Maastricht University Medical Centre+, Maastricht, NetherlandsDepartment of Vascular Surgery, Maastricht University Medical Centre+, Maastricht, NetherlandsIntroduction Current evidence on vascular access strategies for haemodialysis patients is based on observational studies that are at high risk of selection bias. For elderly patients, autologous arteriovenous fistulas that are typically created in usual care may not be the best option because a significant proportion of fistulas either fail to mature or remain unused. In addition, long-term complications associated with arteriovenous grafts and central venous catheters may be less relevant when considering the limited life expectancy of these patients. Therefore, we designed the Optimising Access Surgery in Senior Haemodialysis Patients (OASIS) trial to determine the best strategy for vascular access creation in elderly haemodialysis patients.Methods and analysis OASIS is a multicentre randomised controlled trial with an equal participant allocation in three treatment arms. Patients aged 70 years or older who are expected to initiate haemodialysis treatment in the next 6 months or who have started haemodialysis urgently with a catheter will be enrolled. To detect and exclude patients with an unusually long life expectancy, we will use a previously published mortality prediction model after external validation. Participants allocated to the usual care arm will be treated according to current guidelines on vascular access creation and will undergo fistula creation. Participants allocated to one of the two intervention arms will undergo graft placement or catheter insertion. The primary outcome is the number of access-related interventions required for each patient-year of haemodialysis treatment. We will enrol 195 patients to have sufficient statistical power to detect an absolute decrease of 0.80 interventions per year.Ethics and dissemination Because of clinical equipoise, we believe it is justified to randomly allocate elderly patients to the different vascular access strategies. The study was approved by an accredited medical ethics review committee. The results will be disseminated through peer-reviewed publications and will be implemented in clinical practice guidelines.Trial registration number NL7933.Protocol version and date V.5, 25 February 2021.https://bmjopen.bmj.com/content/12/2/e053108.full |
| spellingShingle | Patrick WHE Vriens Edith M Willigendael Maarten A Lijkwan Friedo W Dekker Chava L Ramspek Michiel W de Haan Çaĝdaş Ünlü Boudewijn DC Heggen Koen E A van der Bogt Marc H Hemmelder Mickaël J C Hiligsmann Magda M van Loon Joris I Rotmans Jan H M Tordoir Geert Willem H Schurink Maarten G J Snoeijs Marijke J Molegraaf Philippe WM Cuypers Denise Nio Cora H Arts Jacobien C Verhave Goos D Laverman Aron S Bode Marcel C Weijmer Bas Govaert Aaltje Y Adema Gijs MJM Welten Michel MPJ Reijnen Marc JH Groeneveld Hans S Brink Jeroen B van der Net Arno Kuijper Hilde PE Peters Roos C van Nieuwenhuizen Rombout R Kruse Yvonne C Schrama Karina A de Groot Karima Farhat Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial BMJ Open |
| title | Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial |
| title_full | Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial |
| title_fullStr | Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial |
| title_full_unstemmed | Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial |
| title_short | Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial |
| title_sort | optimising access surgery in senior haemodialysis patients oasis study protocol for a multicentre randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/2/e053108.full |
| work_keys_str_mv | AT optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT patrickwhevriens optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT edithmwilligendael optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT maartenalijkwan optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT friedowdekker optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT chavalramspek optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT michielwdehaan optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT cagdasunlu optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT boudewijndcheggen optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT koeneavanderbogt optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT marchhemmelder optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT mickaeljchiligsmann optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT magdamvanloon optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT jorisirotmans optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT janhmtordoir optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT geertwillemhschurink optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT maartengjsnoeijs optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT marijkejmolegraaf optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT philippewmcuypers optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT denisenio optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT coraharts optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT jacobiencverhave optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT goosdlaverman optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT aronsbode optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT marcelcweijmer optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT basgovaert optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT aaltjeyadema optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT gijsmjmwelten optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT michelmpjreijnen optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT marcjhgroeneveld optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT hanssbrink optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT jeroenbvandernet optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT arnokuijper optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT hildepepeters optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT rooscvannieuwenhuizen optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT romboutrkruse optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT yvonnecschrama optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT karinaadegroot optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial AT karimafarhat optimisingaccesssurgeryinseniorhaemodialysispatientsoasisstudyprotocolforamulticentrerandomisedcontrolledtrial |