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    Richards Belle2020

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    Álvaro Raúl Conto Moreno
    This document describes a clinical trial protocol to evaluate the clinical and cost-effectiveness of a permissive hypotension strategy versus usual care for critically ill patients aged 65 or older with vasodilatory hypotension. The trial will randomize 2600 patients from 65 UK intensive care units to a target mean arterial pressure range of 60-65 mmHg or usual care. The primary outcome is all-cause mortality at 90 days.

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    Richards Belle2020

    Uploaded by

    Álvaro Raúl Conto Moreno
    4 views2 pages
    This document describes a clinical trial protocol to evaluate the clinical and cost-effectiveness of a permissive hypotension strategy versus usual care for critically ill patients aged 65 or older with vasodilatory hypotension. The trial will randomize 2600 patients from 65 UK intensive care units to a target mean arterial pressure range of 60-65 mmHg or usual care. The primary outcome is all-cause mortality at 90 days.

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    This document describes a clinical trial protocol to evaluate the clinical and cost-effectiveness of a permissive hypotension strategy versus usual care for critically ill patients aged 65 or older with vasodilatory hypotension. The trial will randomize 2600 patients from 65 UK intensive care units to a target mean arterial pressure range of 60-65 mmHg or usual care. The primary outcome is all-cause mortality at 90 days.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    4 views2 pages

    Richards Belle2020

    Uploaded by

    Álvaro Raúl Conto Moreno
    This document describes a clinical trial protocol to evaluate the clinical and cost-effectiveness of a permissive hypotension strategy versus usual care for critically ill patients aged 65 or older with vasodilatory hypotension. The trial will randomize 2600 patients from 65 UK intensive care units to a target mean arterial pressure range of 60-65 mmHg or usual care. The primary outcome is all-cause mortality at 90 days.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Original article

    Journal of the Intensive Care Society


    2020, Vol. 21(4), 281–282
    Evaluating the clinical and ! The Intensive Care Society 2020
    Article reuse guidelines:
    cost-effectiveness of permissive sagepub.com/journals-permissions
    DOI: 10.1177/1751143720971433
    hypotension in critically ill patients journals.sagepub.com/home/jics

    aged 65 years or over with vasodilatory


    hypotension: Protocol for the
    65 randomised clinical trial

    Alvin Richards-Belle1, Paul R Mouncey1, Richard D Grieve2,


    David A Harrison1, M Zia Sadique2, Doreen Henry3,
    Chris Whitman3, Julie Camsooksai4, Anthony C Gordon5,6,
    J Duncan Young7, Kathryn M Rowan1 and
    François Lamontagne8

    Abstract
    Vasodilatory shock is common in critically ill patients and vasopressors are a mainstay of therapy. A meta-analysis
    suggested that use of a higher, as opposed to a lower, mean arterial pressure target to guide titration of vasopressor
    therapy, could be associated with a higher risk of death in older critically ill patients. The 65 trial is a pragmatic, multi-
    centre, parallel-group, open-label, randomised clinical trial of permissive hypotension (a mean arterial pressure target of
    60 -65 mmHg during vasopressor therapy) versus usual care in critically ill patients aged 65 years or over with vaso-
    dilatory hypotension. The trial is conducted in 2600 patients from 65 United Kingdom adult, general critical care units.
    The primary outcome is all-cause mortality at 90 days. An economic evaluation is embedded. The 65 trial received
    favourable ethical opinion from the South Central - Oxford C Research Ethics Committee and approval from the Health
    Research Authority. The results will be presented at national and international conferences and published in peer-
    reviewed medical journals.
    Trial registration: ISRCTN10580502

    Keywords
    Vasopressors, mean arterial pressure, critical care, intensive care, clinical trial

    1
    Clinical Trials Unit, Intensive Care National Audit & Research Centre
    Introduction (ICNARC), London, UK
    2
    To guide treatment with vasopressors, doctors typi- Department of Health Services Research and Policy, London School of
    Hygiene & Tropical Medicine, London, UK
    cally prescribe a mean arterial pressure (MAP) target 3
    Patient Representative, UK
    and bedside nurses continuously adjust the rate of 4
    Critical Care, Poole Hospital NHS Foundation Trust, Dorset, UK
    vasopressor infusions to achieve the target MAP. 5
    Section of Anaesthetics, Pain Medicine and Intensive Care, Imperial
    Previous guidelines recommended maintaining MAP College London, London, UK
    6
    above 65 mmHg, but these were based on low quality Intensive Care Unit, Imperial College Healthcare NHS Trust, St Mary’s
    Hospital, London, UK
    evidence and did not provide guidance for an upper 7
    Kadoorie Centre for Critical Care Research and Education, University
    MAP limit.1 A pooled analysis of two randomised of Oxford, John Radcliffe Hospital, Oxford, UK
    clinical trials (RCTs)2,3 suggested that, with increas- 8
    Centre de Recherche du Centre Hospitalier Universitaire de
    ing age, higher MAP targets may be associated with a Sherbrooke et Faculte de medecine et des sciences de la sante,
    greater risk of death.4,5 An alternative strategy Universite de Sherbrooke, Sherbrooke, Canada
    (termed “permissive hypotension”) is to target blood Corresponding author:
    Paul Mouncey, Clinical Trials Unit, Intensive Care National Audit &
    pressure values below traditional levels to reduce the
    Research Centre (ICNARC), Napier House, 24 High Holborn, London
    exposure to vasopressors and minimise their side WC1V 6AZ, UK.
    effects. Email: [email protected]
    282 Journal of the Intensive Care Society 21(4)

    Study type Status


    The 65 trial is a pragmatic, multi-centre, open-label, Patient recruitment is planned to be complete in the
    RCT of permissive hypotension versus usual care in first quarter of 2019. Results will be disseminated in
    critically ill patients aged 65 years or over with vaso- early 2020.
    dilatory hypotension. Favourable ethical opinion was
    given by South Central – Oxford C Research Ethics Declaration of conflicting interests
    Committee and the trial is approved by the Health The author(s) declared the following potential conflicts of
    Research Authority. interest with respect to the research, authorship, and/or
    publication of this article: ACG reports that outside of
    this work he has received speaker fees from Orion
    Intervention(s)
    Corporation, Orion Pharma and Amomed Pharma. He
    Intervention group: a permissive hypotension strategy has consulted for Ferring Pharmaceuticals, Tenax
    – a MAP target range of 60–65 mmHg during vaso- Therapeutics, Baxter Healthcare, Bristol-Myers Squibb
    pressor therapy. and GSK, and received grant support from Orion
    Control group: Usual care (as per local practices). Corporation, Orion Pharma, Tenax Therapeutics and
    HCA International with funds paid to his institution. All
    other authors declare no conflicts of interest.
    Inclusion and exclusion criteria
    Inclusion: Age 65 years or older; vasodilatory hypoten- Funding
    sion; started infusion (for at least one hour) of vaso- The author(s) disclosed receipt of the following financial
    pressors within prior six hours (if noradrenaline, then a support for the research, authorship, and/or publication
    minimum dose of 0.1 mg kg 1 min 1); adequate fluid of this article: This project was funded by the National
    resuscitation is completed or ongoing; and vasopres- Institute for Health Research (NIHR) Health Technology
    sors expected to continue for six hours or more Assessment (HTA) Programme (project number: 15/80/39).
    Exclusion: Vasopressors being used solely as therapy for ACG is funded by an NIHR Research Professor award
    bleeding, acute ventricular failure (left or right) or post- (RP-2015-06-018) and by the NIHR Imperial Biomedical
    cardiopulmonary bypass vasoplegia; ongoing treat- Research Centre. The views and opinions expressed therein
    ment for brain or spinal cord injury; death perceived are those of the authors and do not necessarily reflect those
    of the HTA Programme, NIHR, NHS or the Department of
    as imminent; and previous enrolment to the 65 Trial.
    Health and Social Care.
    Randomisation is concealed and performed as
    soon as possible after confirming eligibility. Given
    the emergency nature of the treatment, the trial uses References
    research without prior consent, with consent sought 1. Rhodes A, Evans LE, Alhazzani W, et al. Surviving
    after randomisation. sepsis campaign: International Guidelines for
    Management of Sepsis and Septic Shock: 2016.
    Intensive Care Med 2017; 43: 304–377.
    Outcomes 2. Lamontagne F, Meade MO, Hebert PC, et al. Higher
    Primary outcome: All-cause mortality at 90 days. versus lower blood pressure targets for vasopressor ther-
    Secondary outcomes: Receipt and duration of respi- apy in shock: a multicentre pilot randomized controlled
    trial. Intensive Care Med 2016; 42: 542–550.
    ratory and renal support; critical care unit and acute
    3. Asfar P, Meziani F, Hamel JF, et al. High versus low
    hospital length of stay; and cognitive decline and
    blood-pressure target in patients with septic shock. N
    health-related quality of life at 90 days and one
    Engl J Med 2014; 370: 1583–1593.
    year. Economic outcomes include incremental net 4. Lamontagne F, Day AG, Meade MO, et al. Pooled anal-
    monetary benefit (primary), resource use and costs ysis of higher versus lower blood pressure targets for
    at 90 days and one year (secondary). vasopressor therapy septic and vasodilatory shock.
    Intensive Care Med 2018; 44: 12–21.
    Target study size 5. Rochwerg B, Hylands M, Moller MH, et al. CCCS-SSAI
    WikiRecs clinical practice guideline: vasopressor blood
    Two thousand six hundred patients from 65 adult, pressure targets in critically ill adults with hypotension
    general critical care units across England, Wales and vasopressor use in early traumatic shock. Intensive
    and Northern Ireland. Care Med 2017; 43: 1062–1064.

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