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New treatment option for Intensive Care Unit Acquired Weakness
Official title Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2
ClinicalTrials.gov ID: NCT06062303
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patient and/or relative informed and having signed the information and consent form for participation in the study
You likely can't join if
- 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
See the full eligibility 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...
- Patient and/or relative informed and having signed the information and consent form for participation in the study
- 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 treatment 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)
The study team makes the final eligibility decision.
Where it's taking place
- Reims, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Reims, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.