Doppler identified venous congestion in septic shock: protocol for an international, multi-centre prospective cohort study (Andromeda-VEXUS)

Ross Prager; Eduardo Argaiz; Michael Pratte; Philippe Rola; Robert Arntfield; William Beaubien-Souligny; André Y. Denault; Korbin Haycock; Francisco Miralles Aguiar; Jan Bakker; Gustavo Ospina-Tascon; Nicolas Orozco; Bram Rochwerg; Kimberley Lewis; Ibrahim Quazi; Eduardo Kattan; Glenn Hernandez; John Basmaji

doi:10.1136/bmjopen-2023-074843

Doppler identified venous congestion in septic shock: protocol for an international, multi-centre prospective cohort study (Andromeda-VEXUS)

Ross Prager^*, Eduardo Argaiz, Michael Pratte, Philippe Rola, Robert Arntfield, William Beaubien-Souligny, André Y. Denault, Korbin Haycock, Francisco Miralles Aguiar, Jan Bakker, Gustavo Ospina-Tascon, Nicolas Orozco, Bram Rochwerg, Kimberley Lewis, Ibrahim Quazi, Eduardo Kattan, Glenn Hernandez, John Basmaji

^*Corresponding author for this work

Intensive Care

Research output: Contribution to journal › Article › Academic › peer-review

15 Citations (Scopus)

52 Downloads (Pure)

Abstract

INTRODUCTION: Venous congestion is a pathophysiological state where high venous pressures cause organ oedema and dysfunction. Venous congestion is associated with worse outcomes, particularly acute kidney injury (AKI), for critically ill patients. Venous congestion can be measured by Doppler ultrasound at the bedside through interrogation of the inferior vena cava (IVC), hepatic vein (HV), portal vein (PV) and intrarenal veins (IRV). The objective of this study is to quantify the association between Doppler identified venous congestion and the need for renal replacement therapy (RRT) or death for patients with septic shock. METHODS AND ANALYSIS: This study is a prespecified substudy of the ANDROMEDA-SHOCK 2 (AS-2) randomised control trial (RCT) assessing haemodynamic resuscitation in septic shock and will enrol at least 350 patients across multiple sites. We will include adult patients within 4 hours of fulfilling septic shock definition according to Sepsis-3 consensus conference. Using Doppler ultrasound, physicians will interrogate the IVC, HV, PV and IRV 6-12 hours after randomisation. Study investigators will provide web-based educational sessions to ultrasound operators and adjudicate image acquisition and interpretation. The primary outcome will be RRT or death within 28 days of septic shock. We will assess the hazard of RRT or death as a function of venous congestion using a Cox proportional hazards model. Sub-distribution HRs will describe the hazard of RRT given the competing risk of death. ETHICS AND DISSEMINATION: We obtained ethics approval for the AS-2 RCT, including this observational substudy, from local ethics boards at all participating sites. We will report the findings of this study through open-access publication, presentation at international conferences, a coordinated dissemination strategy by investigators through social media, and an open-access workshop series in multiple languages. TRIAL REGISTRATION NUMBER: NCT05057611.

Original language	English
Article number	e074843
Journal	BMJ open
Volume	13
Issue number	7
DOIs	https://doi.org/10.1136/bmjopen-2023-074843
Publication status	Published - 24 Jul 2023

Bibliographical note

Funding Information:
AD has the following disclosures, however, none are relevant to this current research: CAE-Healthcare (2010) speaker bureau, (2020) KOL speaker bureau, Masimo (2017) speaker bureau, Edwards (2019) research (equipment grant) and supported by the Richard I. Kaufman Endowment Fund in Anesthesia and Critical Care (2015). EA has the following disclosures, however, it is not relevant or discussed in this current research: Speaker honoraria from EchoNous. The remaining authors have relevant conflict of interest to declare.

Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Access to Document

10.1136/bmjopen-2023-074843Licence: CC BY-NC

Doppler identified venous congestion in septic shockFinal published version, 603 KBLicence: CC BY-NC

Cite this

Prager, R., Argaiz, E., Pratte, M., Rola, P., Arntfield, R., Beaubien-Souligny, W., Denault, A. Y., Haycock, K., Miralles Aguiar, F., Bakker, J., Ospina-Tascon, G., Orozco, N., Rochwerg, B., Lewis, K., Quazi, I., Kattan, E., Hernandez, G., & Basmaji, J. (2023). Doppler identified venous congestion in septic shock: protocol for an international, multi-centre prospective cohort study (Andromeda-VEXUS). BMJ open, 13(7), Article e074843. https://doi.org/10.1136/bmjopen-2023-074843

@article{fc7be315add14d01b2992b7acfb44251,

title = "Doppler identified venous congestion in septic shock: protocol for an international, multi-centre prospective cohort study (Andromeda-VEXUS)",

abstract = "INTRODUCTION: Venous congestion is a pathophysiological state where high venous pressures cause organ oedema and dysfunction. Venous congestion is associated with worse outcomes, particularly acute kidney injury (AKI), for critically ill patients. Venous congestion can be measured by Doppler ultrasound at the bedside through interrogation of the inferior vena cava (IVC), hepatic vein (HV), portal vein (PV) and intrarenal veins (IRV). The objective of this study is to quantify the association between Doppler identified venous congestion and the need for renal replacement therapy (RRT) or death for patients with septic shock. METHODS AND ANALYSIS: This study is a prespecified substudy of the ANDROMEDA-SHOCK 2 (AS-2) randomised control trial (RCT) assessing haemodynamic resuscitation in septic shock and will enrol at least 350 patients across multiple sites. We will include adult patients within 4 hours of fulfilling septic shock definition according to Sepsis-3 consensus conference. Using Doppler ultrasound, physicians will interrogate the IVC, HV, PV and IRV 6-12 hours after randomisation. Study investigators will provide web-based educational sessions to ultrasound operators and adjudicate image acquisition and interpretation. The primary outcome will be RRT or death within 28 days of septic shock. We will assess the hazard of RRT or death as a function of venous congestion using a Cox proportional hazards model. Sub-distribution HRs will describe the hazard of RRT given the competing risk of death. ETHICS AND DISSEMINATION: We obtained ethics approval for the AS-2 RCT, including this observational substudy, from local ethics boards at all participating sites. We will report the findings of this study through open-access publication, presentation at international conferences, a coordinated dissemination strategy by investigators through social media, and an open-access workshop series in multiple languages. TRIAL REGISTRATION NUMBER: NCT05057611.",

author = "Ross Prager and Eduardo Argaiz and Michael Pratte and Philippe Rola and Robert Arntfield and William Beaubien-Souligny and Denault, {Andr{\'e} Y.} and Korbin Haycock and {Miralles Aguiar}, Francisco and Jan Bakker and Gustavo Ospina-Tascon and Nicolas Orozco and Bram Rochwerg and Kimberley Lewis and Ibrahim Quazi and Eduardo Kattan and Glenn Hernandez and John Basmaji",

note = "Funding Information: AD has the following disclosures, however, none are relevant to this current research: CAE-Healthcare (2010) speaker bureau, (2020) KOL speaker bureau, Masimo (2017) speaker bureau, Edwards (2019) research (equipment grant) and supported by the Richard I. Kaufman Endowment Fund in Anesthesia and Critical Care (2015). EA has the following disclosures, however, it is not relevant or discussed in this current research: Speaker honoraria from EchoNous. The remaining authors have relevant conflict of interest to declare. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2023",

month = jul,

day = "24",

doi = "10.1136/bmjopen-2023-074843",

language = "English",

volume = "13",

journal = "BMJ open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "7",

}

Prager, R, Argaiz, E, Pratte, M, Rola, P, Arntfield, R, Beaubien-Souligny, W, Denault, AY, Haycock, K, Miralles Aguiar, F, Bakker, J, Ospina-Tascon, G, Orozco, N, Rochwerg, B, Lewis, K, Quazi, I, Kattan, E, Hernandez, G & Basmaji, J 2023, 'Doppler identified venous congestion in septic shock: protocol for an international, multi-centre prospective cohort study (Andromeda-VEXUS)', BMJ open, vol. 13, no. 7, e074843. https://doi.org/10.1136/bmjopen-2023-074843

TY - JOUR

T1 - Doppler identified venous congestion in septic shock

T2 - protocol for an international, multi-centre prospective cohort study (Andromeda-VEXUS)

AU - Prager, Ross

AU - Argaiz, Eduardo

AU - Pratte, Michael

AU - Rola, Philippe

AU - Arntfield, Robert

AU - Beaubien-Souligny, William

AU - Denault, André Y.

AU - Haycock, Korbin

AU - Miralles Aguiar, Francisco

AU - Bakker, Jan

AU - Ospina-Tascon, Gustavo

AU - Orozco, Nicolas

AU - Rochwerg, Bram

AU - Lewis, Kimberley

AU - Quazi, Ibrahim

AU - Kattan, Eduardo

AU - Hernandez, Glenn

AU - Basmaji, John

N1 - Funding Information: AD has the following disclosures, however, none are relevant to this current research: CAE-Healthcare (2010) speaker bureau, (2020) KOL speaker bureau, Masimo (2017) speaker bureau, Edwards (2019) research (equipment grant) and supported by the Richard I. Kaufman Endowment Fund in Anesthesia and Critical Care (2015). EA has the following disclosures, however, it is not relevant or discussed in this current research: Speaker honoraria from EchoNous. The remaining authors have relevant conflict of interest to declare. Publisher Copyright: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2023/7/24

Y1 - 2023/7/24

N2 - INTRODUCTION: Venous congestion is a pathophysiological state where high venous pressures cause organ oedema and dysfunction. Venous congestion is associated with worse outcomes, particularly acute kidney injury (AKI), for critically ill patients. Venous congestion can be measured by Doppler ultrasound at the bedside through interrogation of the inferior vena cava (IVC), hepatic vein (HV), portal vein (PV) and intrarenal veins (IRV). The objective of this study is to quantify the association between Doppler identified venous congestion and the need for renal replacement therapy (RRT) or death for patients with septic shock. METHODS AND ANALYSIS: This study is a prespecified substudy of the ANDROMEDA-SHOCK 2 (AS-2) randomised control trial (RCT) assessing haemodynamic resuscitation in septic shock and will enrol at least 350 patients across multiple sites. We will include adult patients within 4 hours of fulfilling septic shock definition according to Sepsis-3 consensus conference. Using Doppler ultrasound, physicians will interrogate the IVC, HV, PV and IRV 6-12 hours after randomisation. Study investigators will provide web-based educational sessions to ultrasound operators and adjudicate image acquisition and interpretation. The primary outcome will be RRT or death within 28 days of septic shock. We will assess the hazard of RRT or death as a function of venous congestion using a Cox proportional hazards model. Sub-distribution HRs will describe the hazard of RRT given the competing risk of death. ETHICS AND DISSEMINATION: We obtained ethics approval for the AS-2 RCT, including this observational substudy, from local ethics boards at all participating sites. We will report the findings of this study through open-access publication, presentation at international conferences, a coordinated dissemination strategy by investigators through social media, and an open-access workshop series in multiple languages. TRIAL REGISTRATION NUMBER: NCT05057611.

AB - INTRODUCTION: Venous congestion is a pathophysiological state where high venous pressures cause organ oedema and dysfunction. Venous congestion is associated with worse outcomes, particularly acute kidney injury (AKI), for critically ill patients. Venous congestion can be measured by Doppler ultrasound at the bedside through interrogation of the inferior vena cava (IVC), hepatic vein (HV), portal vein (PV) and intrarenal veins (IRV). The objective of this study is to quantify the association between Doppler identified venous congestion and the need for renal replacement therapy (RRT) or death for patients with septic shock. METHODS AND ANALYSIS: This study is a prespecified substudy of the ANDROMEDA-SHOCK 2 (AS-2) randomised control trial (RCT) assessing haemodynamic resuscitation in septic shock and will enrol at least 350 patients across multiple sites. We will include adult patients within 4 hours of fulfilling septic shock definition according to Sepsis-3 consensus conference. Using Doppler ultrasound, physicians will interrogate the IVC, HV, PV and IRV 6-12 hours after randomisation. Study investigators will provide web-based educational sessions to ultrasound operators and adjudicate image acquisition and interpretation. The primary outcome will be RRT or death within 28 days of septic shock. We will assess the hazard of RRT or death as a function of venous congestion using a Cox proportional hazards model. Sub-distribution HRs will describe the hazard of RRT given the competing risk of death. ETHICS AND DISSEMINATION: We obtained ethics approval for the AS-2 RCT, including this observational substudy, from local ethics boards at all participating sites. We will report the findings of this study through open-access publication, presentation at international conferences, a coordinated dissemination strategy by investigators through social media, and an open-access workshop series in multiple languages. TRIAL REGISTRATION NUMBER: NCT05057611.

UR - http://www.scopus.com/inward/record.url?scp=85165760562&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2023-074843

DO - 10.1136/bmjopen-2023-074843

M3 - Article

C2 - 37487682

AN - SCOPUS:85165760562

SN - 2044-6055

VL - 13

JO - BMJ open

JF - BMJ open

IS - 7

M1 - e074843

ER -

Doppler identified venous congestion in septic shock: protocol for an international, multi-centre prospective cohort study (Andromeda-VEXUS)

Abstract

Bibliographical note

Access to Document

Other files and links

Fingerprint

Cite this