Relationship Between Pulse Pressure and Stroke Volume in the Critically Ill Patients: The ANDROMEDA-PEGASUS Study

NCT06737614 | Recruiting

• 1 other identifier: 240730006
• Study Type: observational
• Target: 1,500
• Locations: 3 countries
• Sites: 3

Brief Summary

The goal of this study is to assess the predictive capacity of pulse pressure to estimate stroke volume, as assessed by bedside echocardiography in critically ill patients. We hypothesize that pulse pressure will be able to adequately detect low values of stroke volume, and to track changes of stroke volume during commonly used dynamic cardiovascular interventions. Pulse pressure transduced from an arterial line will be measured simultaneously with left ventricular outflow tract velocity time integral in a broad range of critically ill patients. Ancillary clinical, hemodynamic and echocardiographic data will also be registered.

Conditions

Critical Illness

Keywords

pulse pressure; stroke volume

Outcome Measures

Primary Outcomes (2)

• Left ventricular outflow tract velocity time integral

  measured by bedside echocardiography

  1 day

• Pulse pressure

  measured from invasive arterial line

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- During the study period (one or two weeks according to local study team), eligible patients will be identified during morning rounds. Consecutive patients which comply with inclusion and exclusion criteria and consent in participating will be included in the study. A broad range of ICU patients will be included to perform relevant subgroup analysis.

You may qualify if:

• years
• Admitted to ICU
• Functioning arterial line in place

You may not qualify if:

• Pregnancy
• Inadequate arterial line transduction (see below)
• Refusal of consent
• Patient who requires extracorporeal circulation

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Erasmus Medical Center: collaborator
• Fundacion Clinica Valle del Lili: collaborator
• Hospital do Coracao: collaborator

Study Sites (3)

Hospital Do Coracao

São Paulo, Brazil

RECRUITING

Hospital Clinico UC Christus

Santiago, Chile

RECRUITING

Fundacion Valle del Lili

Cali, Colombia

RECRUITING

Related Publications (6)

• Bakker J, Kattan E, Annane D, Castro R, Cecconi M, De Backer D, Dubin A, Evans L, Gong MN, Hamzaoui O, Ince C, Levy B, Monnet X, Ospina Tascon GA, Ostermann M, Pinsky MR, Russell JA, Saugel B, Scheeren TWL, Teboul JL, Vieillard Baron A, Vincent JL, Zampieri FG, Hernandez G. Current practice and evolving concepts in septic shock resuscitation. Intensive Care Med. 2022 Feb;48(2):148-163. doi: 10.1007/s00134-021-06595-9. Epub 2021 Dec 15.

  PMID: 34910228 BACKGROUND

• Hernandez G, Ospina-Tascon GA, Damiani LP, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Granda-Luna V, Cavalcanti AB, Bakker J; The ANDROMEDA SHOCK Investigators and the Latin America Intensive Care Network (LIVEN); Hernandez G, Ospina-Tascon G, Petri Damiani L, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Cavalcanti AB, Bakker J, Hernandez G, Alegria L, Ferri G, Rodriguez N, Holger P, Soto N, Pozo M, Bakker J, Cook D, Vincent JL, Rhodes A, Kavanagh BP, Dellinger P, Rietdijk W, Carpio D, Pavez N, Henriquez E, Bravo S, Valenzuela ED, Vera M, Dreyse J, Oviedo V, Cid MA, Larroulet M, Petruska E, Sarabia C, Gallardo D, Sanchez JE, Gonzalez H, Arancibia JM, Munoz A, Ramirez G, Aravena F, Aquevedo A, Zambrano F, Bozinovic M, Valle F, Ramirez M, Rossel V, Munoz P, Ceballos C, Esveile C, Carmona C, Candia E, Mendoza D, Sanchez A, Ponce D, Ponce D, Lastra J, Nahuelpan B, Fasce F, Luengo C, Medel N, Cortes C, Campassi L, Rubatto P, Horna N, Furche M, Pendino JC, Bettini L, Lovesio C, Gonzalez MC, Rodruguez J, Canales H, Caminos F, Galletti C, Minoldo E, Aramburu MJ, Olmos D, Nin N, Tenzi J, Quiroga C, Lacuesta P, Gaudin A, Pais R, Silvestre A, Olivera G, Rieppi G, Berrutti D, Ochoa M, Cobos P, Vintimilla F, Ramirez V, Tobar M, Garcia F, Picoita F, Remache N, Granda V, Paredes F, Barzallo E, Garces P, Guerrero F, Salazar S, Torres G, Tana C, Calahorrano J, Solis F, Torres P, Herrera L, Ornes A, Perez V, Delgado G, Lopez A, Espinosa E, Moreira J, Salcedo B, Villacres I, Suing J, Lopez M, Gomez L, Toctaquiza G, Cadena Zapata M, Orazabal MA, Pardo Espejo R, Jimenez J, Calderon A, Paredes G, Barberan JL, Moya T, Atehortua H, Sabogal R, Ortiz G, Lara A, Sanchez F, Hernan Portilla A, Davila H, Mora JA, Calderon LE, Alvarez I, Escobar E, Bejarano A, Bustamante LA, Aldana JL. Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock: The ANDROMEDA-SHOCK Randomized Clinical Trial. JAMA. 2019 Feb 19;321(7):654-664. doi: 10.1001/jama.2019.0071.

  PMID: 30772908 BACKGROUND

• Hernandez G, Messina A, Kattan E. Invasive arterial pressure monitoring: much more than mean arterial pressure! Intensive Care Med. 2022 Oct;48(10):1495-1497. doi: 10.1007/s00134-022-06798-8. Epub 2022 Jul 8. No abstract available.

  PMID: 35802139 BACKGROUND

• Westerhof N, Lankhaar JW, Westerhof BE. The arterial Windkessel. Med Biol Eng Comput. 2009 Feb;47(2):131-41. doi: 10.1007/s11517-008-0359-2. Epub 2008 Jun 10.

  PMID: 18543011 BACKGROUND

• Marquez J, McCurry K, Severyn DA, Pinsky MR. Ability of pulse power, esophageal Doppler, and arterial pulse pressure to estimate rapid changes in stroke volume in humans. Crit Care Med. 2008 Nov;36(11):3001-7. doi: 10.1097/CCM.0b013e31818b31f0.

  PMID: 18824912 BACKGROUND

• Convertino VA, Cooke WH, Holcomb JB. Arterial pulse pressure and its association with reduced stroke volume during progressive central hypovolemia. J Trauma. 2006 Sep;61(3):629-34. doi: 10.1097/01.ta.0000196663.34175.33.

  PMID: 16966999 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eduardo Kattan, MD, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

• Glenn Hernandez, MD, PhD

  Full Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Kattan, MD, PhD

CONTACT

+56223543292; e.kattan@gmail.com

Glenn Hernandez, MD, PhD

CONTACT

+56223543292; glennguru@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: May 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: January 30, 2026
• Last Updated: May 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publication
• Access Criteria: De-identified data may be shared upon reasonable request to the principal investigators

Locations

BR (1); CO (1); CL (1)