Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT06062303 En recrutement IDF

Titre

Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)

Type

Interventional

Pathologie

Choc
Choc septique

Phase

N/A

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

février 2024

Date de fin

mai 2026

Dernière mise à jour

12 septembre 2025

Résumé

Over-resuscitation including fluid overload has been associated with increased morbidity (prolonged duration of organ failure) and mortality in septic shock. "One-size-fits-all" resuscitation strategies may increase septic shock mortality. However, clinical studies on individualized resuscitation are lacking. Hemodynamic phenotyping may allow to individualize septic shock resuscitation. The ANDROMEDA-SHOCK trial found that a simple clinical and bedside CRT-targeted resuscitation reduces organ dysfunction and 28-day mortality in septic shock. The current study will examine the hypothesis that a CRT-targeted resuscitation based on hemodynamic phenotyping considering within an decision tree usual bedside clinical parameters such as pulse pressure, diastolic blood pressure, fluid responsiveness and cardiac performance can further decrease mortality in septic shock as compared to usual care.

Détail

Voir le détail Septic shock is associated with a high mortality risk related to progressive tissue hypoperfusion.However, despite extensive research on the best monitoring and resuscitation strategies, many uncertainties remain. Over-resuscitation, particularly when inducing fluid overload, might contribute to a worse outcome. Fluid overload more likely occurs when fluids are administered to fluid unresponsive patients, but also when inappropriate resuscitation goals are pursued, or a "one-size-fit all" strategy is followed. From a hemodynamic point of view, several pathogenic mechanisms determine a progressive circulatory dysfunction While loss of vascular tone and relative hypovolemia predominate in early phases, more complex mechanisms such as endothelial and microcirculatory dysfunction, progressive vasoplegia, and myocardial dysfunction may be involved later. In effect, from a clinical point of view, many patients despite been fluid loaded in pre-intensive care unit settings, are still evidently hypovolemic and benefit from further administration of fluid boluses. Others, however, present very low diastolic arterial pressures reflecting profound vasoplegia, and recent data suggest that these patients may benefit from early norepinephrine instead of fluids[; on the contrary, administering fluids may fail to correct vascular tone and increase the risk of fluid overload[2]. In addition, a recent echocardiography-based study confirms that a relevant myocardial dysfunction is present in a significant number of patients, and that several cardiovascular phenotypes with a potentially different therapeutic approach may be recognized[8]. Unfortunately, despite the availability of most of the parameters at the bedside and research efforts, no universally applicable clinical phenotyping method for septic shock patients has been translated to usual practice. This is particularly problematic since chocardiography is not immediately available in the majority of centers worldwide, and therefore initial decisions on fluid resuscitation are usually based on clinical grounds and tend to follow the one-size-fits-all principle, leading to the risk of fluid overload. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
AP-HP Assistance publique - Hôpitaux de Paris		En recrutement IDF	13/12/2025 07:37:21	Contacter
	AP-HP - Hôpital Ambroise Paré
	AP-HP - Hôpital Bicêtre
	AP-HP - Hôpital Henri Mondor-Albert Chenevier
	AP-HP - Hôpital Lariboisiere-Fernand Widal
	AP-HP - Hôpital Raymond Poincaré
	AP-HP - Hôpital Saint Antoine
	AP-HP - Hôpital Saint Louis
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hôpital Robert Debré, Université de Reims - 51092 - Reims - France	Hamzaoui MD Olfa, PhD	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- Consecutive adult patients (≥ 18 years)

- Patients with septic shock according to Sepsis-3 consensus conference. In short,
septic shock is defined as suspected or confirmed infection, plus hyperlactatemia
and NE requirements due to persistent hypotension, after a fluid load of at least
1000mL in 1h

- Patient and/or relative informed and having signed the information and consent form
for participation in the study

Critère de non inclusion

- More than 4 hours since septic shock diagnosis,

- Anticipated surgery or acute hemodialysis procedure to start during the 6h
intervention period

- Active bleeding,

- Do not resuscitate status,

- Child B-C Cirrhosis

- Underlying disease process with a life expectancy < 90 days and/or the attending
clinician deems aggressive resuscitation unsuitable

- Refractory shock (high risk of death within 24h)

- Pregnancy

- Concomitant severe acute respiratory distress syndrome

- Patients in whom CRT cannot be accurately assessed

- Non-affiliation to a social security scheme or to another social protection scheme

- Patient on AME (state medical aid) (unless exemption from affiliation

- Patient under legal protection (guardianship, curatorship)

- Participation in another interventional study involving human participants or being
in the exclusion period at the end of a previous study involving human participants,
if applicable

- Inability, according to the investigator, to understand the study
(non-French-speaking patient, cognitive disorders)

NCT06062303 - Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)

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