Personalized resuscitation strategy for septic shock patients
Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)
This study tests a personalized approach to treating septic shock by figuring out whether patients need more fluids or medication to see if it helps them recover better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 1 site (Santiago, Santiago Metropolitan) |
| Trial ID | NCT05057611 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a targeted resuscitation strategy based on hemodynamic phenotyping and capillary refill time in patients with septic shock. The approach seeks to personalize initial resuscitation efforts by identifying patients who may benefit from fluid administration versus those who require early norepinephrine to avoid fluid overload. The study will compare this targeted strategy against usual care to determine its effectiveness in reducing mortality and organ dysfunction. By focusing on individual patient needs, the trial hopes to improve outcomes for those suffering from septic shock.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 and older diagnosed with septic shock who meet specific criteria outlined by the Sepsis-3 consensus.
Not a fit: Patients who may not benefit from this study include those with a do-not-resuscitate status, active bleeding, or those whose underlying conditions limit their life expectancy.
Why it matters
Potential benefit: If successful, this study could lead to a more effective and personalized treatment approach for patients with septic shock, potentially reducing mortality rates.
How similar studies have performed: Other studies have shown promise with targeted resuscitation strategies in septic shock, indicating that this approach may lead to improved patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consecutive adult patients (≥ 18 years) with septic shock according to Sepsis-3 consensus conference (septic shock defined as suspected or confirmed infection, plus hyperlactatemia and NE requirements due to persistent hypotension, after a fluid load of at least 1000 mL in one hour) 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.
Where this trial is running
Santiago, Santiago Metropolitan
- Pontificia Universidad Católica de Chile — Santiago, Santiago Metropolitan, Chile (Recruiting)
Study contacts
- Principal investigator: Glenn Hernandez, MD, PhD — Pontificia Universidad Catolica de Chile
- Study coordinator: Glenn Hernandez, MD, PhD
- Email: glennguru@gmail.com
- Phone: 56940209609
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.