Status:
RECRUITING
Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Shock Resuscitation
Lead Sponsor:
Pontificia Universidad Catolica de Chile
Conditions:
Septic Shock
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 grou...
Detailed Description
Fluids are the first-line hemodynamic therapy during septic shock resuscitation, restoring tissue perfusion by effectively increasing cardiac output and oxygen delivery. Nevertheless, resuscitation fl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06568744
Start Date
August 22 2024
End Date
July 1 2026
Last Update
October 2 2024
Active Locations (3)
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1
Hospital Biprovincial Quillota-Petorca
Quillota, Chile
2
Hospital Barros Luco
Santiago, Chile
3
Hospital Clinico UC Christus
Santiago, Chile