Using fluid intolerance signals to improve fluid resuscitation in septic shock patients
Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Shock Resuscitation
This study is testing if using early warning signs of fluid intolerance can help doctors give better fluid treatment to patients with septic shock compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 3 sites (Quillota and 2 other locations) |
| Trial ID | NCT06568744 on ClinicalTrials.gov |
What this trial studies
This multicentric randomized controlled trial aims to compare two fluid resuscitation strategies in patients with septic shock requiring further fluid administration. The intervention group will utilize fluid intolerance signals to guide fluid administration, while the control group will follow standard care for a duration of six hours. The study will assess the impact of both strategies on fluid-induced harm by measuring changes in pulmonary, cardiac, and renal function biomarkers, as well as the resolution of hypoperfusion through capillary refill time and lactate levels. The goal is to identify early signs of fluid intolerance to prevent adverse outcomes associated with fluid overload.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed or suspected of having septic shock, requiring further fluid resuscitation, and exhibiting signs of hypoperfusion.
Not a fit: Patients who may not benefit include those with do-not-resuscitate status, severe acute respiratory distress syndrome, or other severe comorbidities that complicate fluid resuscitation.
Why it matters
Potential benefit: If successful, this approach could significantly reduce fluid-induced harm and improve outcomes for patients with septic shock.
How similar studies have performed: While the integration of fluid intolerance signals is a novel approach, previous studies have highlighted the importance of managing fluid resuscitation in critically ill patients, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed or suspected septic shock * \< 24 hours since diagnosis * Hypoperfusion signal (altered arterial lactate or CRT) that requires further resuscitation * Mechanical ventilation * Positive fluid responsiveness status Exclusion Criteria: * Pregnancy * Do-not-resuscitate status * Acute coronary syndrome * Active bleeding * Severe concomitant acute respiratory distress syndrome (ARDS) (PaO2:FiO2 ratio \< 100) * Anticipated surgery, prone positioning, or renal replacement therapy in the next 6 hours * Refractory shock according to attending physician * BMI \> 40. * Inadequate echocardiographic window
Where this trial is running
Quillota and 2 other locations
- Hospital Biprovincial Quillota-Petorca — Quillota, Chile (Recruiting)
- Hospital Barros Luco — Santiago, Chile (Recruiting)
- Hospital Clinico UC Christus — Santiago, Chile (Recruiting)
Study contacts
- Principal investigator: Eduardo Kattan, MD, PhD — Pontifiia Universidad Catolica de Chile
- Study coordinator: Eduardo Kattan, MD, PhD
- Email: e.kattan@gmail.com
- Phone: +56223543292
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.