The Multicentre Prospective Observational Study on the Management of Septic Shock

NCT07453901 | Not Yet Recruiting

• 1 other identifier: OSS study
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although there are published guidelines for the management of shock in general and septic shock in particular, the extent to which these guidelines are adhered to or achievable is unknown. Our study aims to describe, in a large population of critical care patients, the management procedures for septic shock, the applicability of existing guidelines, and the characteristics of the centres. The primary objective is to assess current clinical practices for the treatment and monitoring of patients with septic shock. The secondary objectives are to investigate the association of current clinical practices for the treatment and monitoring with 28-day all-cause mortality, to assess the association of current clinical practices for the treatment and monitoring with other outcomes, including 90-day all-cause mortality, ICU length of stay, days without renal replacement therapy, days without vasopressors support and days without invasive mechanical ventilation, to assess the factors that influence the disparity of practices, among the severity of the patients, the country, the availability of drugs and devices and to measure the relative frequency of balanced fluid and isotonic saline administration.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• clinical practices for the treatment and monitoring of patients with septic shock

  To assess current clinical practices for the treatment and monitoring, including sequence of their use, of patients with septic shock

  up to day 90

Secondary Outcomes (6)

• association of clinical practices for the treatment with 28-day all-cause mortality

  up to day 90

• association of clinical practices for the hemodynamic monitoring with 28-day all-cause mortality

  up to day 90

• association of clinical practices for the treatment and monitoring with 90-day all-cause mortality

  day 90

• association of clinical practices for the treatment and monitoring with days without renal replacement therapy

  day 90

• association of clinical practices for the treatment and monitoring with days without vasopressor support

  day 90

Study Arms (1)

septic shock patients

Any patients ≥18 years, hospitalization in intensive care unit with a suspected or documented infection and requiring vasopressors

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

Patients ≥18 years, hospitalization in intensive care unit with a septic shock

You may qualify if:

• Age ≥18 years
• Hospitalization in intensive care unit
• Presence of septic shock, defined by the SEPSIS-3 criteria:
• Suspected or documented infection
• Acute elevation of the SOFA score ≥2 points
• Persistent hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level \>2 mmol/L (18 mg/dL) despite adequate volume resuscitation

You may not qualify if:

• Refusal to participate by the patient's relatives or the patient themselves.

Sponsors & Collaborators

• Bicetre Hospital: lead

Related Publications (23)

• Lakbar I, Munoz M, Pauly V, Orleans V, Fabre C, Fond G, Vincent JL, Boyer L, Leone M. Septic shock: incidence, mortality and hospital readmission rates in French intensive care units from 2014 to 2018. Anaesth Crit Care Pain Med. 2022 Jun;41(3):101082. doi: 10.1016/j.accpm.2022.101082. Epub 2022 Apr 25.

  PMID: 35472583 RESULT

• Vincent JL, Jones G, David S, Olariu E, Cadwell KK. Frequency and mortality of septic shock in Europe and North America: a systematic review and meta-analysis. Crit Care. 2019 May 31;23(1):196. doi: 10.1186/s13054-019-2478-6.

  PMID: 31151462 RESULT

• 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 RESULT

• Monnet X, Messina A, Greco M, Bakker J, Aissaoui N, Cecconi M, Coppalini G, De Backer D, Edul VK, Evans L, Hernandez G, Hunsicker O, Ince C, Kaufmann T, Levy B, Malbrain MLNG, Mebazaa A, Myatra SN, Ostermann M, Pinsky MR, Saugel B, Savi M, Singer M, Teboul JL, Vieillard-Baron A, Vincent JL, Chew MS. ESICM guidelines on circulatory shock and hemodynamic monitoring 2025. Intensive Care Med. 2025 Nov;51(11):1971-2012. doi: 10.1007/s00134-025-08137-z. Epub 2025 Nov 14.

  PMID: 41236566 RESULT

• Annane D, Briegel J, Granton D, Bellissant E, Bollaert PE, Keh D, Kupfer Y, Pirracchio R, Rochwerg B. Corticosteroids for treating sepsis in children and adults. Cochrane Database Syst Rev. 2025 Jun 5;6(6):CD002243. doi: 10.1002/14651858.CD002243.pub5.

  PMID: 40470636 RESULT

• Maxime V, Lesur O, Annane D. Adrenal insufficiency in septic shock. Clin Chest Med. 2009 Mar;30(1):17-27, vii. doi: 10.1016/j.ccm.2008.10.003.

  PMID: 19186278 RESULT

• Bauer SR, Wieruszewski PM, Bissell Turpin BD, Dugar S, Sacha GL, Sato R, Siuba MT, Schleicher M, Vachharajani V, Falck-Ytter Y, Morgan RL. ADJUNCTIVE VASOPRESSORS AND SHORT-TERM MORTALITY IN ADULTS WITH SEPTIC SHOCK: A SYSTEMATIC REVIEW AND META-ANALYSIS. Shock. 2025 May 1;63(5):668-676. doi: 10.1097/SHK.0000000000002558. Epub 2025 Feb 7.

  PMID: 39965613 RESULT

• Jozwiak M, Cousin VL, De Backer D, Malbrain MLNG, Monnet X, Messina A, Chew MS; Cardiovascular Dynamics section of the European Society of Intensive Care Medicine. Vasopressin use across shock states: international insights from an international ESICM-endorsed survey: the PRESS Survey. Crit Care. 2025 Jul 3;29(1):273. doi: 10.1186/s13054-025-05505-5.

  PMID: 40611266 RESULT

• Sacha GL, Bauer SR. Optimizing Vasopressin Use and Initiation Timing in Septic Shock: A Narrative Review. Chest. 2023 Nov;164(5):1216-1227. doi: 10.1016/j.chest.2023.07.009. Epub 2023 Jul 20.

  PMID: 37479058 RESULT

• Jozwiak M. Alternatives to norepinephrine in septic shock: Which agents and when? J Intensive Med. 2022 Jun 12;2(4):223-232. doi: 10.1016/j.jointm.2022.05.001. eCollection 2022 Oct.

  PMID: 36788938 RESULT

• Auchet T, Regnier MA, Girerd N, Levy B. Outcome of patients with septic shock and high-dose vasopressor therapy. Ann Intensive Care. 2017 Dec;7(1):43. doi: 10.1186/s13613-017-0261-x. Epub 2017 Apr 20.

  PMID: 28425079 RESULT

• Shi R, Braik R, Monnet X, Gu WJ, Ospina-Tascon G, Permpikul C, Djebbour M, Soumare A, Agaleridis V, Lai C. Early norepinephrine for patients with septic shock: an updated systematic review and meta-analysis with trial sequential analysis. Crit Care. 2025 May 6;29(1):182. doi: 10.1186/s13054-025-05400-z.

  PMID: 40329359 RESULT

• Monnet X, Lai C, Ospina-Tascon G, De Backer D. Evidence for a personalized early start of norepinephrine in septic shock. Crit Care. 2023 Aug 22;27(1):322. doi: 10.1186/s13054-023-04593-5.

  PMID: 37608327 RESULT

• Mekontso Dessap A, AlShamsi F, Belletti A, De Backer D, Delaney A, Moller MH, Gendreau S, Hernandez G, Machado FR, Mer M, Monge Garcia MI, Myatra SN, Peng Z, Perner A, Pinsky MR, Sharif S, Teboul JL, Vieillard-Baron A, Alhazzani W; European Society of Intensive Care Medicine. European Society of Intensive Care Medicine (ESICM) 2025 clinical practice guideline on fluid therapy in adult critically ill patients: part 2-the volume of resuscitation fluids. Intensive Care Med. 2025 Mar;51(3):461-477. doi: 10.1007/s00134-025-07840-1. Epub 2025 Mar 31.

  PMID: 40163133 RESULT

• Vincent JL, Singer M, Einav S, Moreno R, Wendon J, Teboul JL, Bakker J, Hernandez G, Annane D, de Man AME, Monnet X, Ranieri VM, Hamzaoui O, Takala J, Juffermans N, Chiche JD, Myatra SN, De Backer D. Equilibrating SSC guidelines with individualized care. Crit Care. 2021 Nov 17;25(1):397. doi: 10.1186/s13054-021-03813-0. No abstract available.

  PMID: 34789298 RESULT

• Long J, Chen Z, Luo X, Zhen L, Chi X. Fluid resuscitation management in patients with sepsis and septic shock: a network meta-analysis. Am J Emerg Med. 2025 Oct;96:80-90. doi: 10.1016/j.ajem.2025.06.001. Epub 2025 Jun 4.

  PMID: 40540789 RESULT

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Joost Wiersinga W, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Yataco AC, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Executive Summary: Surviving Sepsis Campaign: International Guidelines for the Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):1974-1982. doi: 10.1097/CCM.0000000000005357. No abstract available.

  PMID: 34643578 RESULT

• Winters ME, Sherwin R, Vilke GM, Wardi G. What is the Preferred Resuscitation Fluid for Patients with Severe Sepsis and Septic Shock? J Emerg Med. 2017 Dec;53(6):928-939. doi: 10.1016/j.jemermed.2017.08.093. Epub 2017 Oct 25.

  PMID: 29079487 RESULT

• Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, Angus DC, Rubenfeld GD, Singer M; Sepsis Definitions Task Force. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):775-87. doi: 10.1001/jama.2016.0289.

  PMID: 26903336 RESULT

• Prescott HC, Angus DC. Enhancing Recovery From Sepsis: A Review. JAMA. 2018 Jan 2;319(1):62-75. doi: 10.1001/jama.2017.17687.

  PMID: 29297082 RESULT

• Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.

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• Meyer NJ, Prescott HC. Sepsis and Septic Shock. N Engl J Med. 2024 Dec 5;391(22):2133-2146. doi: 10.1056/NEJMra2403213. No abstract available.

  PMID: 39774315 RESULT

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 RESULT

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Xavier Monnet, MD, PhD

  AP-HP, Service de médecine intensive-réanimation, Hôpital de Bicêtre, DMU 4 CORREVE, Inserm UMR S_999, FHU SEPSIS, CARMAS, Université Paris-Saclay, 78 rue du Général Leclerc, 94270, Le Kremlin-Bicêtre, France.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Monnet, MD, PhD

CONTACT

+33 (0)1 45 21 35 39; xavier.monnet@aphp.fr

Christopher Lai, MD, PhD

CONTACT

+33(0)680821557; christopher.lai@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 6, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-01