The effect of proactive versus reactive treatment of hypotension on postoperative disability and outcome in surgical patients under anaesthesia (PRETREAT) : clinical trial protocol and considerations
© 2024 The Authors..
Background: Intraoperative hypotension has been extensively studied for its association with adverse outcomes. However, small sample sizes and methodological issues limit the causal inference that can be drawn.
Methods: In this multicentre, adaptive, randomised controlled trial, we will include 5000 adult inpatients scheduled for elective non-cardiac surgery under general or central neuraxial anaesthesia. Patients will be either randomly allocated to the intervention or care-as-usual group using computer-generated blocks of four, six, or eight, with an allocation ratio of 1:1. In the intervention arm patients will be divided into low-, intermediate-, and high-risk groups based on their likelihood to experience intraoperative hypotension, with resulting mean blood pressure targets of 70, 80, and 90 mm Hg, respectively. Anaesthesia teams will be provided with a clinical guideline on how to keep patients at their target blood pressure. During the first 6 months of the trial the intervention strategy will be evaluated and further revised in adaptation cycles of 3 weeks if necessary, to improve successful impact on the clinical process. The primary outcome is postoperative disability after 6 months measured with the World Health Organization Disability Assessment Score (WHODAS) 2.0 questionnaire.
Ethics and dissemination: This study protocol has been approved by the Medical Ethics Committee of the University Medical Centre Utrecht (20-749) and all protocol amendments will be communicated to the Medical Ethics Committee. The study protocol is in adherence with the Declaration of Helsinki and the guideline of Good Clinical Practice. Dissemination plans include publication in a peer-reviewed journal.
Clinical trial registration: The Dutch Trial Register, NL9391. Registered on 22 March 2021.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:9 |
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| Enthalten in: |
BJA open - 9(2024) vom: 27. März, Seite 100262 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kant, Matthijs [VerfasserIn] |
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| Links: |
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| Themen: |
Blood pressure |
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| Anmerkungen: |
Date Revised 06.03.2024 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1016/j.bjao.2024.100262 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM369299124 |
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| 100 | 1 | |a Kant, Matthijs |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The effect of proactive versus reactive treatment of hypotension on postoperative disability and outcome in surgical patients under anaesthesia (PRETREAT) |b clinical trial protocol and considerations |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Revised 06.03.2024 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2024 The Authors. | ||
| 520 | |a Background: Intraoperative hypotension has been extensively studied for its association with adverse outcomes. However, small sample sizes and methodological issues limit the causal inference that can be drawn | ||
| 520 | |a Methods: In this multicentre, adaptive, randomised controlled trial, we will include 5000 adult inpatients scheduled for elective non-cardiac surgery under general or central neuraxial anaesthesia. Patients will be either randomly allocated to the intervention or care-as-usual group using computer-generated blocks of four, six, or eight, with an allocation ratio of 1:1. In the intervention arm patients will be divided into low-, intermediate-, and high-risk groups based on their likelihood to experience intraoperative hypotension, with resulting mean blood pressure targets of 70, 80, and 90 mm Hg, respectively. Anaesthesia teams will be provided with a clinical guideline on how to keep patients at their target blood pressure. During the first 6 months of the trial the intervention strategy will be evaluated and further revised in adaptation cycles of 3 weeks if necessary, to improve successful impact on the clinical process. The primary outcome is postoperative disability after 6 months measured with the World Health Organization Disability Assessment Score (WHODAS) 2.0 questionnaire | ||
| 520 | |a Ethics and dissemination: This study protocol has been approved by the Medical Ethics Committee of the University Medical Centre Utrecht (20-749) and all protocol amendments will be communicated to the Medical Ethics Committee. The study protocol is in adherence with the Declaration of Helsinki and the guideline of Good Clinical Practice. Dissemination plans include publication in a peer-reviewed journal | ||
| 520 | |a Clinical trial registration: The Dutch Trial Register, NL9391. Registered on 22 March 2021 | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a blood pressure | |
| 650 | 4 | |a intraoperative hypotension | |
| 650 | 4 | |a myocardial injury | |
| 650 | 4 | |a organ injury | |
| 650 | 4 | |a renal injury | |
| 700 | 1 | |a van Klei, Wilton A |e verfasserin |4 aut | |
| 700 | 1 | |a Hollmann, Markus W |e verfasserin |4 aut | |
| 700 | 1 | |a Veelo, Denise P |e verfasserin |4 aut | |
| 700 | 1 | |a Kappen, Teus H |e verfasserin |4 aut | |
| 700 | 0 | |a PRETREAT study group |e verfasserin |4 aut | |
| 700 | 1 | |a de Klerk, Eline |e investigator |4 oth | |
| 700 | 1 | |a Vernooij, Lisette |e investigator |4 oth | |
| 700 | 1 | |a Otterspoor, Luuk C |e investigator |4 oth | |
| 700 | 1 | |a Cromheecke, Geert-Jan E |e investigator |4 oth | |
| 700 | 1 | |a Huijzer, Marlous |e investigator |4 oth | |
| 700 | 1 | |a Witziers, Jannie |e investigator |4 oth | |
| 700 | 1 | |a Terwindt, Lotte E |e investigator |4 oth | |
| 700 | 1 | |a Bastiaanse, Tim |e investigator |4 oth | |
| 700 | 1 | |a Immink, Rogier V |e investigator |4 oth | |
| 700 | 1 | |a Strypet, Magnus |e investigator |4 oth | |
| 700 | 1 | |a Sperna Weiland, Niek H |e investigator |4 oth | |
| 700 | 1 | |a Wijnberge, Marije |e investigator |4 oth | |
| 700 | 1 | |a Besselink, Marc Gh |e investigator |4 oth | |
| 700 | 1 | |a Vernooij, Lisette M |e investigator |4 oth | |
| 700 | 1 | |a Janmaat, Yvonne C |e investigator |4 oth | |
| 700 | 1 | |a Akkermans, Annemarie |e investigator |4 oth | |
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