Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Sho
The goal of this multicentric randomized controlled trial is to compare, in septic shock patients who require further fluid resuscitation, two strategies of administering fluids. The intervention group will integrate fluid intolerance signals to the decision making process, while the control group will follow standard
| Condition(s) | Septic Shock |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goal of this multicentric randomized controlled trial is to compare, in septic shock patients who require further fluid resuscitation, two strategies of administering fluids. The intervention group will integrate fluid intolerance signals to the decision making process, while the control group will follow standard of care, for a 6 hour study protocol. The main question it aims to answer is 1. To compare the effect of both resuscitation strategies on fluid-induced harm, assessed by the change in pulmonary, cardiac, and renal function biomarkers during the study period. 2. To assess the safety of both resuscitation strategies on hypoperfusion resolution, measured by the improvement of capillary refill time (CRT) and lactate during the study period. 3. To determine the dynamics of the dif |
| Who can participate | 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 |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Lead sponsor | Pontificia Universidad Catolica de Chile |
| Locations | Quillota, Chile; Santiago, Chile; Santiago, Chile |
| Start date | 2024-08-22 |
| NCT ID | NCT06568744 |
| Official listing | https://clinicaltrials.gov/study/NCT06568744 |