RecruitingNot Applicable

Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2

France180 participantsStarted 2024-02-06

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Exclusion Criteria: * 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 d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

A composite of all cause 28-days mortality plus time to cessation of vital support and length of hospital stay

Timeframe: 28 days

Trial details

NCT IDNCT06062303

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

Contact for this trial

Olfa MD Hamzaoui, PhD

0033310736973 ohamzaoui@chu-reims.fr

View on ClinicalTrials.gov More Intensive Care Unit Acquired Weakness trials