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Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock (REACT-SHOCK)

Primary Purpose

Critical Illness, Shock

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individualised MAP target
Sponsored by
Rakshit Panwar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring Relative hypotension

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ICU patients aged greater than or equal to 40 years The patient is deemed to be in shock, defined as clinician-initiated vasopressor/inotropic therapy AND supported by any of the following within the last 24 hours: Lactate level greater than or equal to 2 mmol/l or base deficit greater than or equal to 3 mmol/l, Urine output less than or equal to 0.5 ml/kg/h or <40 ml/h for 2 or more consecutive hours Respiratory rate >22 per minute Altered mentation (Glasgow Coma Score <14) Exclusion Criteria: Patients who are moribund, or have documented not-for-resuscitation orders At least 24 hours have lapsed from the time of initiation of vasopressor or inotropic support Patients who are either receiving or are deemed to imminently need renal replacement therapy. Patients who already have an increase in serum creatinine of >350 µmol/l from baseline. End stage renal disease Patients where trauma is the main reason for the current ICU admission. Previously enrolled in the REACT Shock RCT Pregnancy, if known Active bleeding (clinical suspicion or >2 packed red blood cells within last 24 hours) Insufficient (less than two) pre-illness BP readings are available. Patients on extracorporeal support (such as extracorporeal membrane oxygenation, intra-aortic balloon pump, or ventricular assist device). Potential contraindications to either higher or lower BP targets (including but not limited to) Cerebral perfusion pressure guided therapy e.g. intracranial hemorrhage or subarachnoid hemorrhage or traumatic brain injury Abdominal perfusion pressure guided therapy Aortic injury (e.g. dissection or post-operative) Post cardiac surgery Any other condition requiring higher or lower BP target specifically

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Standard MAP target

    Individualised MAP target

    Arm Description

    The comparator or the control group will be comprised of patients assigned to standard care, where vasopressor support will be titrated to maintain a default MAP of 65 mmHg, unless the treating clinician considers a different MAP target as more appropriate.

    In the intervention arm, a patient's own pre-illness mean arterial pressure (MAP) would be targeted (range: 55-95 mmHg) during vasopressor support in ICU. The pre-illness MAP will be estimated from most recent pre-illness BP readings following a standardized method (Panwar et al,. Blood Press. 2017:1-9) and will be targeted for the duration of vasopressor therapy for up to a maximum of five days. The treating clinician can tailor these BP targets as deemed suitable for current clinical state. The type of vasopressor that will be used is at the discretion of the treating clinician. Study intervention will cease if a patient is considered well enough by the treating clinician for discharge out of ICU. If a patient is transported out of ICU for procedural intervention, then standard (non-study) treatment should be provided.

    Outcomes

    Primary Outcome Measures

    Mortality
    All deaths from randomisation to 14 days

    Secondary Outcome Measures

    Time to death through day 14
    Major Adverse Kidney Events
    Defined as a composite of death, new renal replacement therapy, or final serum creatinine level >= 200% of the latest preillness creatinine level, as assessed from patient medical records.
    Renal replacement therapy free days until day 28
    Peak increase in serum creatinine levels
    Time to death through day 90
    Mortality
    All deaths from randomisation to 90 days

    Full Information

    First Posted
    April 29, 2023
    Last Updated
    April 29, 2023
    Sponsor
    Rakshit Panwar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05850962
    Brief Title
    Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock
    Acronym
    REACT-SHOCK
    Official Title
    Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock - A Multicentre Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    January 2028 (Anticipated)
    Study Completion Date
    January 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Rakshit Panwar

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Aim The aim of the proposed RCT is to determine effectiveness of a strategy, where MAP (mean arterial blood pressure) targets during vasopressor therapy for shock in ICU are individualized based on patients' own pre-illness MAP that would be derived as an average of up to five most recent pre-illness blood pressure readings. Hypothesis We hypothesize that targeting a patient's pre-illness MAP during management of shock can minimize the degree of MAP-deficit (a measure of relative hypotension), which may help reduce the risk of 14-day mortality and major adverse kidney events by day 14 in ICU. Endpoints The primary endpoint will be the all-cause mortality rate at day 14. Secondary endpoints will be the time to death through day 14 and day 90, major adverse kidney events (MAKE-14), renal replacement therapy (RRT) free days until day 28, and 90-day all-cause mortality. Significance To date no major RCT has tested this strategy among ICU patients with shock. This pivotal trial will provide evidence to fulfil a crucial knowledge gap regarding a common and a fundamental intervention in critical care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Illness, Shock
    Keywords
    Relative hypotension

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1260 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard MAP target
    Arm Type
    No Intervention
    Arm Description
    The comparator or the control group will be comprised of patients assigned to standard care, where vasopressor support will be titrated to maintain a default MAP of 65 mmHg, unless the treating clinician considers a different MAP target as more appropriate.
    Arm Title
    Individualised MAP target
    Arm Type
    Active Comparator
    Arm Description
    In the intervention arm, a patient's own pre-illness mean arterial pressure (MAP) would be targeted (range: 55-95 mmHg) during vasopressor support in ICU. The pre-illness MAP will be estimated from most recent pre-illness BP readings following a standardized method (Panwar et al,. Blood Press. 2017:1-9) and will be targeted for the duration of vasopressor therapy for up to a maximum of five days. The treating clinician can tailor these BP targets as deemed suitable for current clinical state. The type of vasopressor that will be used is at the discretion of the treating clinician. Study intervention will cease if a patient is considered well enough by the treating clinician for discharge out of ICU. If a patient is transported out of ICU for procedural intervention, then standard (non-study) treatment should be provided.
    Intervention Type
    Other
    Intervention Name(s)
    Individualised MAP target
    Intervention Description
    The project will test an intervention that initially targets a patient's own pre-illness mean arterial pressure (MAP) during vasopressor support in ICU. The pre-illness MAP will be estimated from the most recent pre-illness BP readings recorded in medical records.
    Primary Outcome Measure Information:
    Title
    Mortality
    Description
    All deaths from randomisation to 14 days
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Time to death through day 14
    Time Frame
    First 14 days of randomisation
    Title
    Major Adverse Kidney Events
    Description
    Defined as a composite of death, new renal replacement therapy, or final serum creatinine level >= 200% of the latest preillness creatinine level, as assessed from patient medical records.
    Time Frame
    14 days from randomisation
    Title
    Renal replacement therapy free days until day 28
    Time Frame
    28 days from randomisation
    Title
    Peak increase in serum creatinine levels
    Time Frame
    28 days from randomisation
    Title
    Time to death through day 90
    Time Frame
    First 90 days of randomisation
    Title
    Mortality
    Description
    All deaths from randomisation to 90 days
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ICU patients aged greater than or equal to 40 years The patient is deemed to be in shock, defined as clinician-initiated vasopressor/inotropic therapy AND supported by any of the following within the last 24 hours: Lactate level greater than or equal to 2 mmol/l or base deficit greater than or equal to 3 mmol/l, Urine output less than or equal to 0.5 ml/kg/h or <40 ml/h for 2 or more consecutive hours Respiratory rate >22 per minute Altered mentation (Glasgow Coma Score <14) Exclusion Criteria: Patients who are moribund, or have documented not-for-resuscitation orders At least 24 hours have lapsed from the time of initiation of vasopressor or inotropic support Patients who are either receiving or are deemed to imminently need renal replacement therapy. Patients who already have an increase in serum creatinine of >350 µmol/l from baseline. End stage renal disease Patients where trauma is the main reason for the current ICU admission. Previously enrolled in the REACT Shock RCT Pregnancy, if known Active bleeding (clinical suspicion or >2 packed red blood cells within last 24 hours) Insufficient (less than two) pre-illness BP readings are available. Patients on extracorporeal support (such as extracorporeal membrane oxygenation, intra-aortic balloon pump, or ventricular assist device). Potential contraindications to either higher or lower BP targets (including but not limited to) Cerebral perfusion pressure guided therapy e.g. intracranial hemorrhage or subarachnoid hemorrhage or traumatic brain injury Abdominal perfusion pressure guided therapy Aortic injury (e.g. dissection or post-operative) Post cardiac surgery Any other condition requiring higher or lower BP target specifically
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rakshit Panwar, PhD, MD, FCICM, MBBS
    Email
    rakshitpanwar@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29040214
    Citation
    Panwar R. Untreated Relative Hypotension Measured as Perfusion Pressure Deficit During Management of Shock and New-Onset Acute Kidney Injury-A Literature Review. Shock. 2018 May;49(5):497-507. doi: 10.1097/SHK.0000000000001033.
    Results Reference
    background
    PubMed Identifier
    32614244
    Citation
    Panwar R, Tarvade S, Lanyon N, Saxena M, Bush D, Hardie M, Attia J, Bellomo R, Van Haren F; REACT Shock Study Investigators and Research Coordinators. Relative Hypotension and Adverse Kidney-related Outcomes among Critically Ill Patients with Shock. A Multicenter, Prospective Cohort Study. Am J Respir Crit Care Med. 2020 Nov 15;202(10):1407-1418. doi: 10.1164/rccm.201912-2316OC.
    Results Reference
    result
    PubMed Identifier
    35525132
    Citation
    Panwar R, Van Haren F, Cazzola F, Nourse M, Brinkerhoff G, Quail A. Standard care versus individualized blood pressure targets among critically ill patients with shock: A multicenter feasibility and preliminary efficacy study. J Crit Care. 2022 Aug;70:154052. doi: 10.1016/j.jcrc.2022.154052. Epub 2022 May 5.
    Results Reference
    result
    PubMed Identifier
    23849541
    Citation
    Panwar R, Lanyon N, Davies AR, Bailey M, Pilcher D, Bellomo R. Mean perfusion pressure deficit during the initial management of shock--an observational cohort study. J Crit Care. 2013 Oct;28(5):816-24. doi: 10.1016/j.jcrc.2013.05.009. Epub 2013 Jul 10.
    Results Reference
    result
    PubMed Identifier
    28745077
    Citation
    Panwar R, Sullohern B, Shiel E, Alexis Brown C, Quail A. Validity of a protocol to estimate patients' pre-morbid basal blood pressure. Blood Press. 2018 Feb;27(1):10-18. doi: 10.1080/08037051.2017.1358055. Epub 2017 Jul 26.
    Results Reference
    result

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    Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock

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